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 Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377)

Event Date 10/28/2020

Event Type  Injury  

Event Description

This complaint is from a literature source. The following literature cite has been reviewed eachempati kk, dannana cs, apsingi s, ponnala vk, boyapati g, parameswaran a. Trunnion fracture of femoral prosthesis following a large metal-on-metal uncemented total hip arthroplasty: a case report. Arthroplasty. 2020 oct 28;2(1):32. Doi: 10. 1186/s42836-020-00055-3. Pmid: 35236457; pmcid: pmc8796406. Adverse event(s) and provided interventions associated with depuy devices: a (b)(6) year-old male patient with juvenile idiopathic arthropathy presented to us with sudden onset pain secondary to a fracture of the trunnion of his left tha, with no history of trauma. Upon entering the joint, the surgeon identified and debrided periarticular metallosis. The stem was fractured at the trunnion and there was evidence of corrosion at the head/neck junction. The cup was well-fixed and revised, there was evidence of osteolysis in the acetabulum. There was no reported product problem with the revised asr xl femoral augment. The patient was revised with competitor products. The procedure was completed without complications. Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: asr xl 54 mm acetabular cup, 47 mm + 6 neck offset asr xl femoral component, asr xl femoral segment, size 14 a+ aml stem.

Manufacturer Narrative

(b)(4). 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13995422
• MDR Text Key: 288490464
• Report Number: 1818910-2022-06055
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 04/04/2022 Patient Sequence Number: 1

Treatment

UNK HIP ACETABULAR CUP ASR; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM