MAUDE Adverse Event Report: DEPUY INT'L 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); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 03/12/2010

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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(6).Ongoing post market surveillance is conducted per our procedures for this product.(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 relationship between the presence of metallosis and massive infection in metal-on-metal hip replacements¿ by james r.Donaldson, et al, published by hip international (2010), vol.20, no.02, pp.242-247, was reviewed.The authors present a small series of a previously unreported complication, which appears specific to metal-on-metal bearing surface arthroplasties: three cases of infection in the presence of local metal debris and histological features of aseptic lymphocytic vasculitis associated lesions (alval).Each case is associated with significant soft tissue loss and bone destruction to such an extent that pelvic discontinuity has occurred.Two of the cases presented were implanted with competitor products and are not included in this complaint.Case 2, with an asr-xl system and corail stem is captured in this complaint." (b)(6) male with asl-xr implant and corail stem.Implanted may 2006.Excision arthroplasty for mrsa infection, worsening pain, and suspected loosening of acetabular component.Intraoperative confirmation of pseudotumor, heterotopic ossification, soft tissue necrosis, acetabular osteolysis with pelvic discontinuity and cup loosening, black metal stained periarticular fluid, pelvic and femoral osteolysis.Patient was not revised as of this writing because his inflammatory and infection markers were still too elevated.Excision performed in june 2008 with positive histological identification of mrsa in the joint.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9288712
• MDR Text Key: 184877320
• Report Number: 1818910-2019-111636
• Device Sequence Number: 1
• Product Code: KXA
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• 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