MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Tissue Damage (2104); Osteolysis (2377); No Code Available (3191)

Event Date 05/03/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4) superseded by mdd capa-(b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿the articular surface replacement implant recall: a united kingdom district hospital experience¿ by george s.Whitwell, et al, published by hip international (2012), vol.22, no.4, pp.362-370, was reviewed.The authors present a detailed patient history of their experience with 21 asr rha and 100 asr-xl modular with a corail femoral stem tha before and after the implant recall- between february 2005 and october 2008.This complaint captures 27 patient experiences with either the asr resurfacing or the asr-xl tha with a corail stem before and after the device recall.At the time of the implant recall in august 2010 there were 111 surviving hips (92%) with a mean follow-up of 44 months.Nine hips had been revised and one had been listed for revision surgery.Ninety-two percent of surviving implants were reviewed in the recall clinics, and blood metal ion levels or ultrasound scans were indicated in 38 hips (34%).Immediately after the recall process seven hips (6 asr/xl and 1 rha) were listed for revision and a further 9 were kept under close surveillance.One year after completion of the recall process 23 hips (19 asr/xl and 4 rha¿s) had been revised.A diagnosis of adverse reaction to metal debris (armd) was made at surgery in all but two hips.Of the 9 patients kept under surveillance, 5 went on to have revisions of the device.There are four patients who have elevated blood ions and pain who have not been recommended for revision surgery.This complaint captures 27 patients.The parent complaint (b)(4) begins with case 1 and the additional cases are in the guidance document labeled case 2-case 27.Cases 24 through 27 have not had revision surgery.Please refer to the attached guidance document for case event descriptions and impacted products.(b)(6) yo male revised asl-xr/corail stem 24 months after index tha due to altr.Radiographic findings: progressive osteolysis in the acetabulum with a loosened cup.Intraoperative findings: the stem was well fixed, presence of pseudotumor confirmed, damage to the periarticular soft tissue and abductor muscles, and gross evidence of metal debris and metallosis as evidenced by periarticular joint fluid collection.No elevated blood metal ions reported.No preoperative pain reported.There were no perioperative complications.The was no reported product problem with the stem.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9259912
• MDR Text Key: 181385541
• Report Number: 1818910-2019-113268
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention