MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 57; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999805057

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 05/03/2017

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.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.

Event Description

It was reported by legal that the patient was revised on (b)(6) 2017 for left total hip arthroplasty.The pre-op diagnosis was failed left hip articular surface replacement arthroplasty.He had elevated acromion and cobalt ions and pain.It was also noted that he had metallosis and a pseudo-tumor.Update ad jan 31, 2018 & feb 23, 2018: medical records and translated document received.After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain, elevated metal ions and pseudotumor.Revision notes reported metal staining.There were no lab results provided.Associated complaint (b)(4) (right hip revision).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(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(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: TOTAL ASR FEM IMP SIZE 57
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7302568
• MDR Text Key: 101144639
• Report Number: 1818910-2018-54248
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2011
• Device Catalogue Number: 999805057
• Device Lot Number: 2088706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/26/2018
• Date Device Manufactured: 02/22/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 105