MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC; CERAMIC ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER CERAM

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

Patient Problems Ossification (1428); Post Operative Wound Infection (2446)

Event Date 03/01/2021

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: lee sj, yoon ks.Two-stage total hip arthroplasty following skeletal traction after extensive soft tissue release for severe limb-length discrepancy.Hip int.2021 mar;31(2):223-230.Doi: 10.1177/1120700019865742.Epub 2019 jul 21.Pmid: 31328568.Objective and methods: this retrospective study evaluates 2-stage tha results following limb lengthening via skeletal traction after extensive soft tissue release in 24 hips with pre-existing ddh or sepsis causing severe lld implanted between 2004 to 2015.The patients received the thas in two-stages.In the first stage, extensive soft-tissue release was performed.Then the patient was put into traction for two weeks to lengthen the shortened leg.In stage two, the patients received the tha.The authors utilized 2 competitor cemented stems with competitor acetabular components, 9 s-rom/duraloc option ceramic on ceramic (coc) tha, 1 s-rom/pinnacle coc, 8 summit/duraloc option coc.2 trilock/pinnacle coc, and 2 summit/pinnacle coc thas.There is insufficient information within the text of this article to determine adverse event according to device manufacturer.The actual number of depuy products associated with each reported adverse event is unknown.As there is insufficient information to determine the complications/adverse events as they relate to a specific device or manufacturer, this complaint will capture one ip for each tha components and all patient harms with a quantity of one.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: and unknown femoral stem, ceramic femoral head, ceramic acetabular liner, acetabular cup, and femoral s-rom sleeve adverse event(s) and provided interventions associated with depuy devices: 2 instances of non-union of osteotomy site treated with stem revision.1 superficial wound infection treated with surgical debridement and component retention.3 cases of radiologically identified heterotopic ossification- no treatment specified.

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: UNK HIP ACETABULAR LINER CERAMIC
• Type of Device: CERAMIC ACETABULAR LINER
• 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: 15084108
• MDR Text Key: 296388074
• Report Number: 1818910-2022-13686
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• 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 CERAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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