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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Unspecified Infection (1930); No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

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.(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

"literature article entitled, ¿total hip arthroplasty in osteonecrosis secondary to sickle cell disease¿ by mohamed zubair farook, et al, published by international orthopaedics (2018), 6 pages, https://doi.Org/10.1007/s00264-018-4001-0, was reviewed.In this retrospective study, the authors analyzed the outcome of tha in a cohort of patients with sickle cell disease.The authors studied 32 thas between 1999 and 2016 from an scd database.Co-morbidities, both sickle and non-sickle-related, were documented.Complications and indications for revision surgery were analyzed.Both competitor and depuy products were used in the study.Implanted depuy products: 4 s-rom thas and 17 pinnacle/corail thas.The articulations were either mop, mom, or cop.All depuy products were cementless.The cemented components used were all competitor products.The revisions for cemented products are not included in this complaint.Results: the complications listed are for all competitor and depuy products.There is insufficient information to determine if the complications are attributed to depuy or competitor products.8 cases heterotopic ossification.1 pulmonary embolism.1 femoral shaft perforation during stem implantation.1 revision of a corail/pinnacle system for deep infection at 2-years.4 acetabular revisions for polyethylene wear and acetabular osteolysis.1 patient had an acetabular periprosthetic fracture secondary to osteolysis.This patient¿s cup was retained, and the liner revised and cemented with unknown cement.Captured in this complaint: stem, cup, liner, head, and s-rom sleeve.".

• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 9339426
• MDR Text Key: 184989727
• Report Number: 1818910-2019-116774
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/18/2019
• 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