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); Positioning Problem (3009)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 09/11/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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, ¿clinical and radiological outcome of the newest generation of ceramic-on-ceramic hip arthroplasty in young patients¿ by avishai reuven, et al, published by advances in orthopedic surgery (12 february 2014), volume 2014, article id 863748, 6 pages, http://dx.Doi.Org/10.1155/2014/863748, was reviewed for mdr reportability.In this study, the authors retrospectively evaluated the short- to mid-term clinical and radiographic results in 51 consecutive patients (61 hips) using the biolox ceramic articulating surfaces with depuy pinnacle cup and a variety of depuy stems.The aim of this study was to retrospectively evaluate the short- to midterm clinical and radiographic outcome after primary total hip replacements using the fourth generation ceramic biolox delta implants.Implanted products: biolox delta femoral heads and acetabular liners are the focus of this study.All patients received one of four cementless pinnacle acetabular cups (pinnacle 100, pinnacle 300, pinnacle bantam, pinnacle multi-hole ii; depuy) and one of five cementless femoral stems (summit, prodigy, trilock, corail, or s-rom; depuy).Acetabular fixation with screws was used based on the patient¿s bone quality.Results: at the time of the final follow-up, there was no radiographic evidence of component loosening and no evidence of implant subsidence, liner fracture or dislocation.All components were stable and osseous-integrated.There was a case of deep infection requiring a two-stage revision.One female patient presented with audible repetitive ¿squeaking¿ noise that began after a fall 2 years postoperatively.She had a 36mm head and she was able to reproduce the squeaking in the office with walking.The cup was found to be in a nonoptimal position, measuring 58° of inclination and 19° of anteversion.The patient was completely pain-free and she refused a revision surgery.This retrospective study demonstrates that biolox delta bearings provided good to excellent overall functioning outcomes with no implant related complications or osteolysis.Captured within this complaint: 1 total revision for infection (1cup, head, liner, and stem, and 1 augment), 1 case of mispositioned cup, 1 case of implant noise: 1 head and 1 liner.".

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up 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 46581 0988
• MDR Report Key: 9214790
• MDR Text Key: 217165222
• Report Number: 1818910-2019-109319
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 11/12/2019
• Supplement Dates FDA Received: 10/29/2019; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1