MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2023

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

Liner breakage post-op.More than 9 months after bilateral hip arthroplasty, the patient had left hip movement sound.The patient went to the hospital for examination, and it was found by x-ray that the ceramic liner implanted on the left side was cracked.A second surgery was required, but the timing of the second surgery is currently uncertain.

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 ceramic insert was found fractured into multiple fragments.Additionally, signs of metal transfer can be observed on the inner surface and on the fractured fragments, most likely caused by chafing between metal parts and the fragments of insert.Based on the observations, it reasonable to conclude that audible sound would be present.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 insert belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the 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 [121881752 / 3719590] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Event Description

Additional information was received and stated that the patient underwent a second procedure on (b)(6) 2023.The fractured liner and worn hip femoral head were removed.Replaced with new ceramic head and acetabular liners.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17099407
• MDR Text Key: 316932952
• Report Number: 1818910-2023-12009
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881752
• Device Lot Number: 3719590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Treatment: UNKNOWN HIP FEMORAL HEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 71 KG