MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Disorder (2373); Osteolysis (2377); No Code Available (3191)

Event Date 04/29/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Literature article entitled, ¿five duraloc locking ring failures¿ by cara c.Powers, et al, in the journal of arthroplasty (2010) vol.25, no.7, pp.15-18 was reviewed for mdr reportability.The authors report on 5 cases that underwent revision for locking ring failure in the duraloc product line (depuy, warsaw, ind).All liner retrievals showed signs of posterior neck/liner impingement and superior edge loading or significant wear.In these cases, we believe superior head migration and neck/liner impingement due to cup anteversion contributed to these locking ring failures.All of these cases were performed through a posterolateral approach.After the patients were identified, their clinic notes and radiographs were reviewed retrospectively.Retrieved implants were examined.Each case report is listed within the event description spreadsheet case 1-5 with specific patient consequences and impacted products.Case 3 of 5.In 1995, a (b)(6) year old man underwent a right tha through a standard posterolateral approach using a 54-mm duraloc 100 cup, +4-mm polyethylene liner, and a +5, 28-mm ceramic head.The inclination and anteversion of the cup were 46° and 32°, respectively.He did not follow up with the clinic after his 6-month postoperative visit until 2002 when he complained of a 3-year history of increasing right hip pain.He denied any symptoms of subluxation or dislocation.Radiographs revealed locking ring failure, eccentricity of the femoral head, and pelvic and femoral osteolysis.A liner exchange was performed using a +4-mm marathon cross-linked liner (depuy, warsaw, ind) and a 28-mm cobalt-chrome head.The explanted liner showed severe superior wear, scratches from locking ring fragments on the articular surface, and signs of posterior head/neck impingement.When the patient returned for routine follow-up 7 years after the liner exchange, the replacement locking ring was fragmented, but he was asymptomatic.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8977211
• MDR Text Key: 161515689
• Report Number: 1818910-2019-103642
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention