MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

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

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Inadequate Osseointegration (2646); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.The device catalog number is unknown; therefore, udi is unavailable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled ¿revision arthroplasty using a custom-made implant in the course of acetabular loosening of the j&j depuy asr replacement system - case report " written by aleksander augustyn, md, tomasz stoltny, phd , dominika rokicka, phd , marta wróbel, phd , jan pajak, md, krystian werner, md , karol ochocki, md , krzysztof strojek, phd , bogdan koczy, phd, published by medicine open on 8-aug-2022 was reviewed.The aim of the study was to evaluate the effectiveness of surgical treatment with a custom-made implant in a patient with extensive acetabular bone loss after aseptic loosening of the acetabular component of the j&j depuy asr surface prosthesis in the early period of observation.A 74-year-old patient was taken to the orthopaedic trauma emergency room due to increasing pain in the right hip for about 3months.Nine years earlier he underwent resurfacing arthroplasty of the right hip using the j&j depuy asr method.Asr right hip revision due to: leg length discrepancy, pain, limited rom, fracture of acetabulum.Preoperative radiographs were noted to show pseudotumors and osteolysis.During the revision, the surgeon observed metallosis, aseptically loosened acetabular cup, extensive bone loss.The asr components were removed and then the patient underwent 2.5 years to assess the reconstruction within the bone defect after cancellous bone allografting was done.3 years after previous revision, the patient had definitive implants put in, which included competitor custom made acetabular cup and a depuy corail stem.The outcome noted optimal implant adherence to the bone base and full osseointegration with the pelvic bone had been achieved.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15484918
• MDR Text Key: 300580841
• Report Number: 1818910-2022-18705
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention