MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical adverse event received for adverse local tissue reaction/high cobalt level 5.3 mcg/l event is serious and is considered severe event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2005.Date of event (onset): (b)(6) 2020 (left hip).Treatment: hip revised on (b)(6) 2020, of head and liner.

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.Corrected: h6 (medical device problem code).

Event Description

Revision operative notes dated (b)(6) 2020 indicated that the patient received a left total hip revision due to bearing wear of the articulating metal surface.Upon entering the joint, extensive chronic inflammation was encountered.Mild corrosion was identified on the femoral head and trunnion of the stem.The backside of the liner and topside of the cup showed brown-red metallosis.The liner and head were revised, cup and stem were noted to be well fixed, cleaned and left implanted.The surgery was completed without indication of complication by the surgeon.

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 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 (dhr) review, was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10905373
• MDR Text Key: 218493684
• Report Number: 1818910-2020-25492
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; S-ROM*HEAD FEMRL ALUMINA 32+6; S-ROM*SLVE ZTTOVSZ 24F-LRG22ID; SROM STM STD 36+12L 17X22
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113