MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; HIP METAL ACETABULAR LINERS

Catalog Number 121887352

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Metal Related Pathology (4530); Physical Asymmetry (4573)

Event Date 08/17/2023

Event Type  Injury  

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

It was reported that the surgeon exchanged an ultramet liner with an altrx liner.Patient needed additional leg length so femoral head was exchanged for a 8.5 ts.There was no surgical delay.Doi: unknown.Dor: (b)(6) 2023.Affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that the surgeon exchanged an ultramet liner with an altrx liner.Patient needed additional leg length so femoral head was exchanged for a +8.5 ts.There was no surgical delay.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "pc-(b)(4) x-ray film ad 1 sep 2023." the x-ray evidence review revealed that the pinnacle mtl ins neut36idx52od presented no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for pinnacle mtl ins neut36idx52od.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that 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: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: HIP METAL 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17702118
• MDR Text Key: 322880502
• Report Number: 1818910-2023-18290
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; UNK HIP FEMORAL STEM TRI-LOCK
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male