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

Catalog Number 121881756

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2023

Event Type  malfunction  

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

It was reported that the liner broke intra-op.During the surgery of total hip arthroplasty, the ceramic liner broke at the rim.All pieces were removed.Another polyethylene liner was used to complete the procedure resulting in a 40min delay.The patient was in stable condition now.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary- the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirm the reported allegation.The rim of the ceramic liner was found fracture into multiple pieces.Fragments, can be seen on the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - the ceramic inserts belongs to the shop order 7011686671.Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the ceramic insert confirmed to the specification valid at the time of production.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 pre-existing material defect.Device history review - a manufacturing record evaluation was performed for the finished device [121881756 / 3907510] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: g4 (510k).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - liner breakage intra-op.During the surgery of total hip arthroplasty, ceramic liner was broken at the rim.All pieces were removed.Another polyethylene liner was used to complete the procedure resulting in a 40min delay.The patient was in stable condition now.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with supplier investigation performed by supplier.Further details of the device's analysis were attached on "231115 final report kiv 23 08 02.Pdf".Visual analysis of the returned sample revealed that delta cer insert 36id x 56od has fractured into multiple pieces, one large and two small fragments were returned for evaluation.However, the ceramic insert cannot be completely reconstructed from the delivered fragments.Next to the fracture surface, metal transfer can be observed which indicates small areas of intensive contact between the ceramic insert and the metal cup.Additionally, metal transfer of erratic appearance can be found on the outer surface of the rim this could be possibly due to the attempts to remove the ceramic from the metal cup.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the delta cer insert 36id x 56od may have been caused by a misalignment during the process of positioning the insert.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences.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 / 3907510] 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 pre-existing material defect.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 - the ceramic inserts belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the ceramic insert confirmed to the specification valid at the time of production.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 pre-existing material defect.Device history review - a manufacturing record evaluation was performed for the finished device [121881756 / 3907510] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: d9 h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirm the reported allegation.The rim of the ceramic liner was found fracture into multiple pieces.Fragments, can be seen on the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device [121881756 / 3907510] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DELTA CER INSERT 36ID X 56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17290170
• MDR Text Key: 319204317
• Report Number: 1818910-2023-13830
• Device Sequence Number: 1
• Product Code: MRA
• 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
• Report Date: 07/10/2023

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: 3907510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 09/05/2023; 11/17/2023; 11/29/2023
• Supplement Dates FDA Received: 09/06/2023; 11/19/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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
• Patient Age: 59 YR