MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Anemia (1706); Unspecified Infection (1930); Thrombosis (2100); Joint Dislocation (2374); No Code Available (3191)

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.

Event Description

On 22-may-2019 literature article entitled: ¿retentive cup arthroplasty in selected hip fracture patients¿a prospective series with a minimum 3-year follow-up¿.The study¿s objective was to evaluate the efficacy of the use of retentive cup primary total hip replacement in high-dislocation risk subcapital fracture patients.A review of 354 patients during the years 2008 to 2012, with displaced subcapital fractures was conducted.Of the 354 patients, 87 fulfilled the inclusion criteria and underwent constrained total hip.The models of prostheses used include competitor liner, competitor cup, unspecified depuy femoral head, 85 depuy corail hip system and 2 depuy cemented stem (c-stem).The study identified the following to be implant related adverse outcomes: 2 patients had clinically evident deep vein thrombosis requiring long-term anticoagulation.72 patients received blood transfusions due to a drop in hemoglobin.2 patients experienced dislocation, noted to be due to ring displacement.2 patients experienced joint infection.Of those, one was treated with a girdle stone; the other with a revision of the femoral head.3 patients developed brooker i heterotopic ossification.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8692478
• MDR Text Key: 147771903
• Report Number: 1818910-2019-95803
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention