MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

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

Patient Problems Adhesion(s) (1695); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Occupation is lawyer.(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

Plaintiff¿s preliminary disclosure and asr medical record received.After review of medical record, patient was revised to address left hip pain.Patient had elevated metal ion.Revision notes stated that there was a lot of fluid in the hip, there was a lot of tissue that appeared black in nature and appeared like corrosion.Pseudocapsule and old scar were excised.Acetabular component and head were removed with minimal bone loss.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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.A mre (device history record) review will not be performed.

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11615852
• MDR Text Key: 243832496
• Report Number: 1818910-2021-07071
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 999800312
• Device Lot Number: 2476122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT POR TAPER SZ7 HI OFF; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT POR TAPER SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR