MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TAPER SLEEVE ADAPTER 12/14 +8; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800108

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

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191)

Event Date 07/06/2012

Event Type  Injury  

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 (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore no dhr (device history record) review for this individual asr component will be carried out at this point in time.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.The investigation to determine root cause was conducted under mdd (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.No 510(k) number provided because this implant product code was sold internationally.It was sold in the us under a different product code.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Reporter is a non-healthcare professional.(b)(4).

Event Description

Litigation alleges elevated metal ions, cracking noises of the prosthesis, discomfort, trauma, disfigurement,emotional distress, loss of amenity and injury.Doi: (b)(6) 2009; dor: (b)(6) 2012; right hip.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  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 = null.Device history batch = null.Device history review = null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAPER SLEEVE ADAPTER 12/14 +8
• 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: 8439946
• MDR Text Key: 139443776
• Report Number: 1818910-2019-88013
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• 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: 03/04/2019

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 Catalogue Number: 999800108
• Device Lot Number: 2388859
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 06/10/2019
• Supplement Dates FDA Received: 03/21/2019; 06/10/2019
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR