MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 TAPER SLEEVE ADAPTER 12/14 +2; FEMORAL SLEEVE

Catalog Number 999800102

Device Problems Corroded (1131); Nonstandard Device (1420)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Weakness (2145); Discomfort (2330)

Event Date 10/06/2017

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 (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 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

Claim letter and scf received.Scf reports weakness, ambulation difficulties, discomfort, metal ions above 7 ug/l, pseudotumor, erosive changes, tenderness, pain upon rotation, armd, corrosion, and fatty atrophy.

• Brand Name: TAPER SLEEVE ADAPTER 12/14 +2
• Type of Device: FEMORAL SLEEVE
• 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: 7084667
• MDR Text Key: 93804075
• Report Number: 1818910-2017-50823
• Device Sequence Number: 0
• Product Code: KWA
• Reporter Country Code: EI
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800102
• Device Lot Number: 2762372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Date Device Manufactured: 10/22/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention