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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Osteolysis (2377); No Code Available (3191)

Event Date 09/30/2009

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.(b)(4).

Event Description

Literature article received entitled "outcomes of isolated acetabular revision".Literature article entitled, ¿outcomes of isolated acetabular revision,¿ by brian m.Lawless, md, et al, published by clinical orthopedic related research (2010), vol.468, pp.472-479 from the symposium presented at the hip society meetings 2009 was reviewed for mdr reportability.The authors retrospectively reviewed and evaluated 42 isolated acetabular revision operations and investigated the impact of patient age, diagnosis, bone stock, bone loss, bone augmentation, and obesity on pain and the harris hip score between february 1993 and november 2005.Preoperative radiographs were graded according to paprosky et al.Postoperative radiographs were graded according to moore et al.And for implant position, prosthetic fixation, and osteolysis.Complications, patient outcome, reoperations, and acetabular re-revisions were recorded.All patients had complete clinical and radiographic follow-up with a minimum follow-up of 2 years (mean, 6.4 years; range, 2¿13 years).The acetabular implants came from a variety of manufacturers, those from depuy were the pinnacle and duraloc acetabular cup and a constrained liner.There were screws used in the placement of some acetabular cups, though the authors do not specify which ones.Five hips (12%) were revised.Three hips (7.3%) had acetabular re-revision for aseptic acetabular loosening at 6.7 years, 7.0 years, and 11.3 years.One hip was treated for infection at 6 months with successful two-stage resection and reimplantation.One hip had an isolated femoral revision with retention of the revised acetabulum for a traumatic femoral fracture at 9 years.Radiographically, there were 3 cases of superior migration, 1 case of a broken screw, and one case of osteolysis.Most of the patients reported some pain ranging from mild to moderate.There were no reports of dislocation or instability after re-revision among the studied cohort.The authors do not differentiate patient harms with specific implants or manufacturers.

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.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 LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9028854
• MDR Text Key: 162361504
• Report Number: 1818910-2019-104317
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention