MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Ischemia (1942); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Joint Dislocation (2374)

Event Date 08/04/2013

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, "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.Subramanian 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

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.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 FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9174602
• MDR Text Key: 173007483
• Report Number: 1818910-2019-108510
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention