MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804550

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Itching Sensation (1943); Rash (2033); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 03/31/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.  the correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.

Event Description

(b)(6) asr claim letter received.T was further alleged that during the revision surgery, the femoral head was found to have mobilized, with partial resorption of the femoral neck and presence of metal debris with infiltration of the joint capsule.This prompted the need for an osteotomy of the femoral neck and removal of the capsule which was infiltrated with metallosis debris.Additionally, patient reports of intense itching, associated with the diffuse dermatitis, complete disability, injury and elevated blood and urine chromium and cobalt levels.

Event Description

In addition to what was previously alleges.Claim letter alleges during revision there's mobilization of the surface of the head and partial reabsorption of the femoral neck, metallic debris around the joint, bone and soft tissues.Claimant suffers from dermatitis throughout the body.

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.Replaced surgical intervention with device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ASR ACETABULAR IMPLANT 50
• 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: 8835742
• MDR Text Key: 152469743
• Report Number: 1818910-2019-99446
• 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: foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999804550
• Device Lot Number: 2328673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 50; TOTAL ASR FEM IMP SIZE 45
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR