MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 45; HIP FEMORAL HEAD

Catalog Number 999890245

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Cyst(s) (1800); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/15/2017

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.

Event Description

Asr litigation received.Litigation alleges injury, pain, stiffness, discomfort, weakness, limited mobility, anxiety, emotional distress and elevated metal ion levels.Doi: (b)(6) 2008; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, the patient was revised due to right total hip arthroplasty failure secondary to adverse local soft tissue reaction and cystic mass.It was also confirmed that patient had elevated metal levels.Revision notes stated that patient had an erosion in the mid portion of the junction of the it band, soft tissue destruction, inflammed and hypertrophied synovium, and necrosis, bone loss, osteolysis there was very little corrosion on stem and sleeve interface, majority of the corrosion was between the sleeve and the head.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 45
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7216536
• MDR Text Key: 98126303
• Report Number: 1818910-2018-51885
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2013
• Device Catalogue Number: 999890245
• Device Lot Number: 2602796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• Date Device Manufactured: 04/18/2008
• 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: 59 YR