MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881756

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

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.

Event Description

Liner breakage intra-op.It was reported that patient underwent total hip replacement.The ceramic liner was found to be fractured during the procedure, then all the fragments were retrieved and cleared.Changed another liner to complete the surgery.No procedure delay was reported.The patient was in stable condition now.

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.

Event Description

Additional information was received: a.Affected side: left.B.The edge of the ceramic liner was brushed.C.The event occurred during primary surgery.

Event Description

Additional information received.The procedure delay time was about 30 mins.

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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, ¿liner breakage intra-op.It was reported that patient underwent total hip replacement.The ceramic liner was found to be fractured during the procedure, then all the fragments were retrieved and cleared.Changed another liner to complete the surgery.No procedure delay was reported.The patient was in stable condition now.¿ the product was not returned to depuy synthes, however photos were provided for review.(b)(4).Review of the photographic evidence revealed that the delta cer insert 36id x 56od has a portion of the rim fractured into multiple pieces.Several small fragments can be observed on the provided evidence.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during the surgical process.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 [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect.The overall complaint was confirmed as the observed condition of the ceramic liner would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to component failure.No corrective and/or preventative action is proposed.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 [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿liner breakage intra-op.It was reported that patient underwent total hip replacement.The ceramic liner was found to be fractured during the procedure, then all the fragments were retrieved and cleared.Changed another liner to complete the surgery.No procedure delay was reported.The patient was in stable condition now.¿ the product was not returned to depuy synthes; however, photos were provided for review.See attachment "(b)(4)." review of the photographic evidence revealed that the delta cer insert 36id x 56od has a portion of the rim fractured into multiple pieces.Several small fragments can be observed on the provided evidence.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during the surgical process.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 [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect.The overall complaint was confirmed as the observed condition of the ceramic liner would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to component failure.No corrective and/or preventative action is proposed.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 [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: liner breakage intra-op.It was reported that patient underwent total hip replacement.The ceramic liner was found to be fractured during the procedure, then all the fragments were retrieved and cleared.Changed another liner to complete the surgery.No procedure delay was reported.The patient was in stable condition now.The product returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with a manufacturing investigation performed by supplier.Visual analysis of the returned device revealed that delta cer insert 36id x 56od has the rim fracture.Two broken fragments were returned for evaluation, one large and one small.Metal transfer of erratic appearance was found on the liner.In case of symmetrical taper fit between the ceramic liner and the acetabular cup, metal transfer patters are expected over the whole circumference of the center and top section of the taper.The liner does not present such patterns.Additionally, metal transfer can be found on the bottom section of the taper this could indicate a tilted position of the liner during the impaction.Next to the fractured area, metal transfer can be found which indicates small areas of intensive contact between the ceramic liner and the acetabular cup.Therefore, it is assumed that the liner fractured due to a point load caused by a misaligned position of the insert in the acetabular cup.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of aby pre-existing material defect.A manufacturing record evaluation was performed for the finished device [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors.Consideration must be given to all potential influences during the surgical process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.The overall complaint was confirmed as the observed condition of the delta cer insert 36id x 56od 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 reported 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: protocols and acceptance certificate were reviewed.The quality documents shows that the data obtained on the ceramic liner conformed to the specification valid at the time of production.Device history review: a manufacturing record evaluation was performed for the finished device [121881756 / 3836345] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of aby pre-existing material defect.

• Brand Name: DELTA CER INSERT 36ID X 56OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18989262
• MDR Text Key: 338738308
• Report Number: 1818910-2024-06898
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295268345
• UDI-Public: (01)10603295268345(17)270630(10)3836345
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070026
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881756
• Device Lot Number: 3836345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/02/2024; 04/15/2024; 04/17/2024; 04/25/2024; 08/14/2024
• Supplement Dates FDA Received: 04/04/2024; 04/18/2024; 04/21/2024; 04/25/2024; 08/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male