MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890246

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Unspecified Tissue Injury (4559)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. 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 record, it was reported that the patient was revised for failed left tha with recalled metal on metal on metal design with massive pelvic associated bone loose and pseudotumor. Operative notes reported that there was a chronic non-union of greater trochanteric fracture. There was a dense dark gray organized mass protruding from the posterior pseudo capsule. There were areas within the mass of frank necrosis. Debrided intracapsular tissue that was similarly consistent with pseudotumor. There was gross evidence of taper junction corrosion with black debris along the trunnion. There was extensive black necrotic pastry debris behind the cup. The anterior column was largely absent down into a significant portion of the pubic root. There was essentially no anterior wall. There was a significant cavity extending up the ilium similarly filled with black pasty debris that was debrided. Doi: (b)(6) 2009, dor: (b)(6) 2020, left hip.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 46
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12547659
• MDR Text Key: 273807970
• Report Number: 1818910-2021-21422
• 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: consumer,other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 999890246
• Device Lot Number: 2783222
• 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: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2008
• 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 Treatment Data

Date Received: 09/29/2021 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; S-ROM*SLEEVE PRX ZTT, 16D-SML; SROM STM ST,36+6L NK,11X16X150