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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/24/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional narrative: 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 "a comparison of a conventional versus a short, anatomical metaphyseal-fitting cementless femoral stem in the treatment of patients with a fracture of the femoral neck" by y-h.Kim and j-h.Oh published by the journal of bone and joint surgery doi:10.1302/0301-620x.94b6.29152 on june 2012 was reviewed for reportability.The purpose: "the purpose of this study was to compare prospectively the clinical and radiological outcomes, mortality and complication rates, and revision rates of cementless thr performed using a short, anatomical metaphyseal-fitting cementless femoral stem versus a conventional diaphyseal-fitting fully porous coating cementless stem in a consecutive group of physically and mentally healthy patients with an acute garden iii or iv14 fracture of the femoral neck." the article reports includes data from 70 patients who received proxima stems and 70 received aml stems with both utilizing ceramic modular heads and cementless pinnacle acetabular cups with ceramic liners.The article reports: "osseo-integration was seen in all the femoral and acetabular components.No acetabular or femoral component migrated by > 2 mm and no rlls were detected around the porous-coated surface of any acetabular or femoral components on the ap or lateral radiographs." deaths were noted but were noted one year of operations with two being in short stem group and three were in the conventional stem group but cause of death for those are unknown or clarified.However, one death explained to be caused by pneumonia and septic shock (listed as complications from surgery) occurred one month after the index operation (this particular patient had a short stem who sustained a post-operative peri-prosthetic fracture at the tip of the sem).Complications for post-operative from table iv: urinary tract infection (7 of short stem and 15 of conventional stem); mental status change (7 of short stem and 15 of conventional stem); transfusion reaction (1 of short stem); acute renal failure (1 of short stem and 3 of conventional stem); pneumonia (2 of short stem and 3 of conventional stem) and pulmonary microemboli (11 of conventional stem); also noted are dislocations (1 of short stem and 4 in conventional stem) which were revised or treated with closed reduction; infection treated with intravenous antibiotics).One patient was identified and captured on a linked complaint.

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 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: 8989336
• MDR Text Key: 161736091
• Report Number: 1818910-2019-103924
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention