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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Anxiety (2328); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

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. Initial reporter occupation: lawyer. (b)(4). 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

English translation of (b)(6) legal document received. This is a request for initiation of mediation procedure alleging progressively severe pain, limping gait, instability, functional limitations of the lower limb, inflammation, presence of accumulation of chromium and cobalt metal ions in the patient's blood leading to metallosis and presence of a voluminous cyst in the right coxofemoral region. The document further indicates that the patient developed moderate to severe persistent depressive disorder related to stress directly connected to the consequences of the trauma suffered by the patient, partly increased by her knowledge of the damage caused by having the depuy asr prosthetic system. This resulted to severe anxiety and significant obsessive-phobic manifestations, depressed mood, excessive irritability and reactivity. Doi: somewhere between (b)(6) 2009 - dor: no revision reported (right hip).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9410074
• MDR Text Key: 169054291
• Report Number: 1818910-2019-120140
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 12/04/2019 Patient Sequence Number: 1