MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Anxiety (2328); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

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.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.

Event Description

Asr claim letter received.Claim letter alleges strong and constant pain, difficulty ambulating, elevated metal ion levels, muscular, renal and cardiac deficit, local and generalized toxicity from chromium-cobalt with complicating cancerous pathology to the urogenital apparatus, anxiety and depression for one's state of health, damage and oncology to the genital apparatus, uncertain gait, functional limitations of the joint, local swelling and easy fatigue.It was also stated that plaintiff was implanted with asr xl.Doi: (b)(6) 2007 ; dor: not reported (left hip).Patient is bilateral, see (b)(4) for right side.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's 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 46581-0988 ; 5743725905
• MDR Report Key: 7420971
• MDR Text Key: 105136278
• Report Number: 1818910-2018-57094
• 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: consumer,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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
• Date Manufacturer Received: 03/21/2018
• 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