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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/18/2010

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)(4).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, ¿femoral component neck fracture after failed hip resurfacing arthroplasty¿ by pieter k.Bos, md, phd, et al, published by the journal of arthroplasty (2011), vol.26, no.8, 3 pages, doi:10.1016/j.Arth.2010.11.017, was reviewed.The authors present a case of the occurrence of a stemmed femoral implant neck fracture in a patient who was earlier treated for a failed hip resurfacing.A (b)(6) male, 88 kg, bmi 28.4, received an uncomplicated asr hemiarthroplasty for treatment of osteoarthritis of the right hip.The patient had two previous unspecified hip surgeries and had an unknown screw fixation of the greater trochanter.After 8 weeks of rehabilitation and recovery, the patient sustained a femoral neck fracture while walking.At this revision, the cup was well-fixed and left in situ.The femoral head was revised to an asr-xl modular head with sleeve and an elite plus stem- size 4 with a 9/10 taper.Following revision, the patient complained of clicking in the joint and radiographs revealed anterior impingement and subluxation during deep flexion.29 months after revision, the patient experienced a sharp groin pain and fell while walking.Radiographs revealed a femoral component neck fracture at the stem-sleeve junction.Intraoperatively, hypersensitivity was confirmed by the presence of brown stained periarticular fluid and a thickened joint capsule.Histological studies confirmed the presence of inflammatory markers and did not show any signs of infection.The authors note that there was no evidence of aval and did not test for metallosis.The patient received a full revision.The cup was found to be out of alignment and there was wear on the superolateral side due to impingement of the fractured stem that happened during the 10 days between the stem fracture and revision surgery.Macro and microscopic examination of the explanted components revealed the stem fractured at the edge of the union with the taper sleeve adapter (asr taper sleeve adapter (-3 mm, [taper 9/10] and asr unipolar femoral head 55 mm [taper 9/10]).No material or geometry defects as a potential cause of fracture were identified.No specific defect could be identified at the origin of the fatigue crack.The implants used during the re-revision are unknown.The patient has had no further complications at the time of last follow-up.Captured in this complaint: first revision: asr hemiarthroplasty femoral head for periprosthetic fracture post-op and pain second revision: asr cup for mispositioning and bearing wear, asr-xl femoral head for bearing wear, asr-xl femoral sleeve with no reported product problem, elite plus stem for implant fracture post-op".

• 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: 9280339
• MDR Text Key: 184872516
• Report Number: 1818910-2019-111605
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/05/2019
• 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: 10/14/2019
• 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