MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

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

Patient Problems Unspecified Infection (1930); Ischemia (1942); Renal Failure (2041); Thrombosis (2100)

Event Date 08/04/2013

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

The literature article entitled, "cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial" written by a.S.Gavaskar, n.C.Tummala, and m.Sub mammalian published by musculoskeletal surg (2014) 98:205¿208 doi 10.1007/s12306-013-0296-6 on 4 august 2013 was reviewed for mdr reportability.The article reports on patients greater than 80 years old who received tha between march 2006 and january 2009 with depuy implants.Group i consisted of 31 patients with cemented c-stem with ogee cup and group 2 consisted of 31 patients with cementless duraloc shell augmented with screws and a poly liner with collarless corail or summit stem.The femoral head was 28mm metal without indication of platform but suggestive towards depuy product.Nine total patients died with 3 in the perioperative period (all in group 1) with one dying during cementing process mid surgery and 6 unrelated to implants or procedure.Group i had the following results and complications that required interventions: 20 transfusions, 1 calcar intra-op associated to 1 dislocation due to subsidence attributed to calcar fracture who required revision, 1 acetabular aseptic loosening requiring revision.Group 1 also had noted complications without clarification of specific interventions provided: 1 etopic ossification, 1 dvt, 1 pe, 1 acute renal failure, 1 silent mi, 2 cardiac ischemia, and 1 pulmonary infection.Group 2 had the following results and complications that required interventions: 15 transfusions, 3 intra-op fractures treated with cerclage wiring, 2 dislocations with closed reductions and immobilizations.Group 2 also had noted complications without clarification of specific interventions provided: 1 dvt, 1 acute renal failure, 1 cardiac ischemia, and 1 pulmonary infection.The article does not identify product name of cement.

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).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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.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 IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9174672
• MDR Text Key: 173008164
• Report Number: 1818910-2019-108128
• 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
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention