MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Osteolysis (2377)

Event Date 12/06/2017

Event Type  Injury  

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.

Event Description

(b)(4).Osteolysis + high ions levels cr-co.Doi: (b)(6) 2007; dor: (b)(6) 2017; unknown affected side.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7175112
• MDR Text Key: 96744791
• Report Number: 1818910-2018-50645
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/13/2017

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: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/09/2018
• 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