MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928146
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was revised due to premature wear of polyethylene.Patient admitted to make polyethylene replacement on 04/16/2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "the hcp request study of the following reference implanted in the hº hm model on 26/05/2021 - surgeon - adeslas surgery - episode e140278.-1219-28-146 with lot: j9753a".The product was not returned to depuy synthes, however photos were provided for review.See attachment (_external_ incidencia 121928146.Msg).Photos were provided for review, however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.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: a manufacturing record evaluation was performed for the finished device j9753a and no non-conformances or manufacturing irregularities were identified.
Additional 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 that 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.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "the hcp request study of the following reference implanted in the hº hm model on 26/05/2021 - surgeon - adeslas surgery - episode e140278.-1219-28-146 with lot: j9753a" the product was not returned to depuy synthes, however photos were provided for review.See attachment (_external_ incidencia 121928146.Msg).Photos were provided for review, however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.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 a manufacturing record evaluation was performed for the finished device j9753a and no non-conformances or manufacturing irregularities were identified.
Additional 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received: "the hcp request study of the following reference implanted in the hº hm model on 26/05/2021 - surgeon - adeslas surgery - episode e140278 -1219-28-146 with lot: j9753a.Patient admitted to make polyethylene replacement on (b)(6) 2023 - we have the material removed to send to j&j." and "premature wear of polyethylene".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the lip of the pinn mar +4 10d 28idx46od fractured in uneven patterns, including the anti-rotational mechanism tabs.Not all broken fragments were returned for evaluation.Additionally, the device surface had signs of being implanted for a period of time.Although there is no specific root cause established for the fractured observed, the reported allegation can be confirmed as a fracture on the anti-rotational mechanism may had happen as a consequence of the wear observed, leading to an edge loading and ultimately to the fracture.However, consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations, patient changes over time and the extraction procedure.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device j9753a and no non-conformances or manufacturing irregularities were identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test 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 +4 10d 28idx46od would have contributed 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 reported complaint condition.As part of j&j medtech orthopaedics 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: a manufacturing record evaluation was performed for the finished device j9753a and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device j9753a and no non-conformances or manufacturing irregularities were identified.

• Brand Name: PINN MAR +4 10D 28IDX46OD
• Common Device Name: 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: 19489465
• Report Number: 1818910-2024-12565
• Device Sequence Number: 7089698
• Product Code: LPH
• UDI-Device Identifier: 10603295013440
• UDI-Public: 10603295013440
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 121928146
• Device Lot Number: J9753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 11/25/2024; 12/04/2024; 12/27/2024; 01/24/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/25/2024; 11/28/2024; 12/06/2024; 01/02/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +5 BR.; PINN MAR +4 10D 28IDX46OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown