MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Noise, Audible (3273)

Patient Problems Wound Dehiscence (1154); Ossification (1428); Fatigue (1849); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Unf and medical records received.After review of medical records patient was revised to addressed painful metal on metal left hip arthroplasty.Prior to revision patient alleged weakness, click in her hip that be heard and felt, elevated cobalt level.Sharp dissection down to fascia layer was performed, upon exposure to the trochanter there was obvious prior repair and subsequent dehiscence of the anterior gluteus medius.Noticeable large protrusion of heterotopic ossification was removed.Acetabular screws were noted, one(1) of which appeared to be slightly prominent in the cup, this was removed.Doi: (b)(6) 2007, dor: (b)(6) 2019 left hip.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR LINER METAL
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11731484
• MDR Text Key: 247487768
• Report Number: 1818910-2021-08839
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 36 MM METAL HEAD.; 36 MM METAL LINER.; 6.5 MM SCREW.; S3 CEMENTLESS SUMMIT POROUS COATED STEM.; 36 MM METAL HEAD; 36 MM METAL LINER; 6.5 MM SCREW; S3 CEMENTLESS SUMMIT POROUS COATED STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR