MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800754

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: 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

Litigation and medical records received.After review of medical records.It was reported that the patient was complaining of significant pain, as well as elevated indices in regard to her metal-on-metal evaluation.The patient was then revised for failed left tha.Operative notes reported that surgeon removed that femoral head and sleeved over the trunnion, there was significant metal on metal debris.There was approximately 20 ml of dark brown fluid that was aspirated.There had very minimal, if any, ingrowth bone on the cup.After the cup was removed, patient did have a significant inferior lysis as well as metal on metal debris in that region as well as significant anterior capsular as well as psoas tendon metal on metal reaction.Patient also has a fair amount of bleeding, which was controlled bovie as well as aquamantys.Doi: (b)(6) 2009, dor: (b)(6) 2016, 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 (b)(6)2010, and the asr product codes are now considered inactive.A mre (device history record) review will not be performed.H10 additional narrative: added: b7.

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.

Event Description

In addition to what were previously reported and after review of the medical records, the patient was revised to address mom failed left tha and instability.Operative note reported significant instability.Doi: (b)(6) 2009, dor: (b)(6) 2016 , left hip.

• Brand Name: ASR ACETABULAR CUPS 54
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11615050
• MDR Text Key: 243808352
• Report Number: 1818910-2021-07020
• 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: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800754
• Device Lot Number: 2956624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 09/23/2021
• Supplement Dates FDA Received: 04/27/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; PRODIGY LG STAT SHT RT 10.5MM; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; PRODIGY LG STAT SHT RT 10.5MM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR