MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 121936056

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision surgery due to ard¿s had fractured off.One fractured ard was found during revision.Doi: unknown.Doe: (b)(6) 2023.Affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: ard¿s have fractured off, one fractured ard was found during revision.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) re product complaint - marathon 3656 liners].The photo investigation revealed that pinn mar neut 36idx56od has fractured the ards, the the root cause can not be established.However the reported condition can be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut 36idx56od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mrae) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : ard¿s have fractured off, one fractured ard was found during revision.The product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4)].The photo investigation revealed that pinn mar neut (b)(6) has ards fractured, a definitive root cause can not be determined with the information provided.However based on the time it was implanted and the results from the dhr review that no manufacturing issue was identified that could have been related to the reported condition, the surgical process is suspected.With the information available it is unknown if the poly liner fractured while implanted or during the extraction process.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut (b)(6) would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4) were manufactured per met specification.2) date of manufacture: 02/23/2023 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028 5) ifu reference: ifu-0902-00-701 rev.T.Device history review: 1) quantity manufactured: (b)(4) were manufactured per met specification.2) date of manufacture: 02/23/2023 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028 5) ifu reference: ifu-0902-00-701 rev.T.

Manufacturer Narrative

Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10 concomitant if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received from sales rep: information received from surgeon 'liners in place in situ but deformed and rotating freely and lugs destroyed.' please update liner for deformed/bent, implant disassociation and add ip for cup for disassociation.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that ard¿s have fractured off, one fractured ard was found during revision the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinn mar neut 36idx56od has three ards fractured.Therefore, the broken condition can lead to the dissociation of the cup from the liner, and it can be observed in the cup that there was dissociation, as evidenced by the transfer of material between the cup and the ceramic head.No deformation or bending of the liner is observed.A definitive root cause can not be determined with the information provided.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut 36idx56od would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be determined, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028 5) ifu reference: ifu-0902-00-701 rev.Device history review : 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028 5) ifu reference: ifu-0902-00-701 rev.T.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinn mar neut 36idx56od has three ards fractured.Therefore, the broken condition can lead to the dissociation of the cup from the liner, and it can be observed in the cup that there was dissociation, as evidenced by the transfer of material between the cup and the ceramic head.No deformation or bending of the liner is observed.A definitive root cause can not be determined with the information provided.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed since it was not applicable to the complaint condition.¿the overall complaint was confirmed as the observed condition of the pinn mar neut 36idx56od would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be determined, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023; 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028; 5) ifu reference: ifu-0902-00-701 rev.T.Device history review: 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023; 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028; 5) ifu reference: ifu-0902-00-701 rev.T.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinn mar neut 36idx56od has three ards fractured.Based on the evidence provided the liner appears to have been edged loaded causing eccentric wear in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards) allowing for the liner to disassociate from the cup.Furthermore, it can be observed, as a result of the disassociation between the liner and cup, evidence of material transfer between the cup and the ceramic head.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn mar neut 36idx56od would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure.No corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023.3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028.5) ifu reference: ifu-0902-00-701 rev.T.Device history review: 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023.3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028.5) ifu reference: ifu-0902-00-701 rev.T.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that ard¿s have fractured off, one fractured ard was found during revision the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinn mar neut 36idx56od has three ards fractured.Based on the evidence provided the liner appears to have been edged loaded causing eccentric wear in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards) allowing for the liner to disassociate from the cup.Furthermore, it can be observed, as a result of the disassociation between the liner and cup, evidence of material transfer between the cup and the ceramic head.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed since it was not applicable to the complaint condition.¿the overall complaint was confirmed as the observed condition of the pinn mar neut 36idx56od would contribute to the complained device issue.Based on the investigation findings, the potential cause is not established, however, there is no indication that a design or manufacturing issue has caused or contributed to the complaint condition.No corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023, 3) any anomalies or deviations identified in dhr: (b)(4) parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028, 5) ifu reference: ifu-0902-00-701 rev.T.Device history review : 1) quantity manufactured: (b)(4) parts were manufactured per met specification.2) date of manufacture: 02/23/2023 3) any anomalies or deviations identified in dhr: 2 parts were scraped with no correlation with the complained condition, 2 unrelated ncs were raised.4) expiry date: 28 / january / 2028 5) ifu reference: ifu-0902-00-701 rev.T.

• Brand Name: PINN MAR NEUT 36IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17487460
• MDR Text Key: 320669286
• Report Number: 1818910-2023-16376
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014461
• UDI-Public: 10603295014461
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K010171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121936056
• Device Lot Number: 4091686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 09/07/2023; 09/29/2023; 10/12/2023; 11/07/2023; 11/24/2023; 11/24/2023; 12/15/2023; 01/18/2024; 01/30/2024; 01/31/2024
• Supplement Dates FDA Received: 09/08/2023; 10/03/2023; 10/13/2023; 11/15/2023; 11/27/2023; 11/27/2023; 12/18/2023; 01/22/2024; 01/30/2024; 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINNACLE SECTOR II CUP 56MM; UNK HIP ACETABULAR CUP; UNK HIP FEMORAL HEAD CERAMIC
• Patient Outcome(s): Required Intervention