MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TOTAL ASR ACET IMP SIZE 46; HIP ACETABULAR CUP

Catalog Number 999804146

Device Problem Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

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.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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reason(s) for revision: alval / soft tissue reaction, pain, noise.

Manufacturer Narrative

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

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 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.H6 patient code: no code available (3191) used to capture the device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the asr platform was voluntarily recalled from the market in (b)(6) 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.

• Brand Name: TOTAL ASR ACET IMP SIZE 46
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6421106
• MDR Text Key: 70459629
• Report Number: 1818910-2017-15087
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999804146
• Device Lot Number: 2232507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 9; DEPUY ASR XL FEM IMP SIZE 41; TAPER SLEEVE ADAPTER 12/14 +2
• Patient Outcome(s): Required Intervention