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

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: kaseb mh, shafiee sh, shamabadi a, aminjavaheri sa, mortazavi smj.Cementless total hip arthroplasty in haemophilia patients through direct anterior approach.Haemophilia.2021 mar;27(2):e239-e244.Doi: 10.1111/hae.14224.Epub 2021 feb 2.Pmid: 33529379.Objective and methods: authors conducted a retrospective review of 12 patients diagnosed with haemophilia, who received 14 total hip arthroplasties (tha), to assess outcomes of tha using direct anterior approach (daa) in patients with haemophilia.Patients received non-cemented hip prosthesis from one of three manufacturers, with depuy pinnacle cup and corail femoral stem being used in seven patients.Liner and femoral head details were not provided.The patients were all male, and data was provided by case number and age of the patients.Results: the mean duration of clinical follow-up was 69 months (with a range of 36 to 96 months).Survey scores were good.Only one patient with simultaneous bilateral daa tha required blood transfusion.It was observed that complications of cementless tha using daa in haemophilia patients with hip arthropathy are comparable to other surgical approaches, yet the complication of bleeding in this approach might be less.Depuy hip complications by case number: case 5: age 42, simultaneous bilateral tha, experienced severe haemorrhage, treated with blood transfusion.Case 11: age 26, intraoperative calcar femur fracture, non-displaced, treated with orif cerclage wire.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15056329
• MDR Text Key: 296181453
• Report Number: 1818910-2022-13443
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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 ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• 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