MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890243

Device Problem Naturally Worn (2988)

Patient Problems Wound Dehiscence (1154); Cyst(s) (1800); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Impaired Healing (2378); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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.

Event Description

Medical records received. After review of medical records, the patient was revised to address aseptic loosening, acetabular protusio, pseudotumor secondary to metal on metal reaction, rupture of adductor tendon mechanism and fascial dehiscence. Prior to being revised, patient reports pain. Workup elsewhere reveals a loose cup with acetabular protusio and rotation of the cup into a passive vertical position. Intraoperatively, a cystic mass was opened and there was milky, non-purulent fluid consistent with metal on metal disease. The abductors were repaired. It was confirmed that the acetabular component was loose and had rotated 90 degrees into the base of the acetabulum. Metal on metal metallic debris was found in the posterior acetabular wall as well as on the trunnion. Doi: (b)(6) 2009; dor: (b)(6) 2019 (right hip).

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary
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> no device associated with this report was received for examination. 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 43
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• 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 orthopedics drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9490559
• MDR Text Key: 184878092
• Report Number: 1818910-2019-123850
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 999890243
• Device Lot Number: 2842733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/18/2019 Patient Sequence Number: 1