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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2009

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

The literature article entitled, "mid-term results using a cementless hip prosthesis in young chinese patients: a five- to seven-year follow-up study" written by xueyong qiu & jing yang & bin shen & zongke zhou & hui zhang & fuxing pei published by international orthopaedics (sicot) (2009) 33:1507¿1512 doi 10.1007/s00264-008-0705-x on 3 december 2008 was reviewed for mdr reportability.The article's purpose: "the goal of this prospective study was to assess clinical and radiographic results of cementless tha with aml stems and to determine advantages and limitations of these stems." data was compiled from 74 thas (69 patients) between july 2000 and june 2002 with follow ups from 5-7 years of 46 men and 23 women with average age of 47 years.Depuy products utilized: aml stems, duraloc 300 cups (without screw hole), poly liner and locking ring, a crco femoral head (presumably depuy as no other indication of other products utilized).The article provides patient identifiers with adverse event (s) for two patients that are captured on a linked complaints.This complaint captures a (b)(6) female who experienced severe pain in the groin and the femoral head was about to wear through the polyethylene liner.At seven years follow-up, the anteroposterior radiograph shows osteolysis in delee and charnley zone 2 which was confirmed by ct.After removal of the osteolysis granuloma, the surgeons filled the cyst with cancellous autograft and replaced the poly liner and the femoral head component.Three months later the patient had excellent clinical function without pain.

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.Additional narrative: corrected: evaluation codes.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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, 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 46581 0988
• MDR Report Key: 9183992
• MDR Text Key: 173014015
• Report Number: 1818910-2019-109483
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR