MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loose or Intermittent Connection (1371); Nonstandard Device (1420); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); 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as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4) superseded by mdd capa (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).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 with asl-xr implant and corail femoral stem.Elective cup and head revision after device recall due to suspected altr and pain 40 months after index tha.Radiographic findings: thickening of the periarticular soft tissue, femoral osteolysis identified on progressive radiographic studies, cup not well-fixed.Intraoperative findings: stem well-fixed, periarticular soft tissue intact, no evidence of pseudotumor, gross evidence of metal debris, presence of periarticular joint fluid with diffuse metallosis.There was no evidence of elevated blood metal ions or soft tissue necrosis.There were no reported product problems with the stem.There were no reports of perioperative complications.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 9260561
• MDR Text Key: 182469466
• Report Number: 1818910-2019-113325
• Device Sequence Number: 1
• Product Code: LPH
• 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 ACETABULAR CUP
• Was Device Available for Evaluation?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR