MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problem Device-Device Incompatibility (2919)

Patient Problem Pain (1994)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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: garfinkel jh, gladnick bp, pachter cs, cochrane nh, romness dw.Perioperative factors associated with increased length of stay after revision of metal-on-metal total hip arthroplasty.J orthop.2019 jan 17;16(2):109-112.Doi: 10.1016/j.Jor.2019.01.003.Pmid: 30723360; pmcid: pmc6352741.Objective and methods: authors investigated patient factors influencing length-of-stay (los) after revision metal-on-metal (mom) total hip arthroplasty (tha).They reviewed 23 hips undergoing revision of a mom tha with minimum 2-year follow-up.Authors performed a retrospective review asking the following research questions: 1) what perioperative factors in patients undergoing revision of metal-on-metal total hip arthroplasty affect hospital length of stay after surgery? 2) what is the incidence of major complications (infection, dislocation) and re­revision after mom tha revision surgery? 3) what are the patient reported clinical outcomes after mom tha revision surgery? sixteen hips underwent acetabular component revision for a recalled acetabular implant (asr'", depuy synthes, warsaw, in); four hips underwent modular head-liner exchange to a highly cross-linked polyethylene liner and ceramic head in the setting of a well-fixed, well-positioned acetabular component (pinnacle, depuy synthes, warsaw, in); two hips underwent acetabular component revision for a well-fixed, well-positioned acetabular component in which the modular cocr liner was cold-welded to the implant and could not be dislodged (pinnacle, depuy synthes, warsaw, in); and one hip was a previous hip resurfacing (competitor system) in which the acetabular component was revised and a primary femoral stem was placed.A multiple linear regression was calculated to predict los using multiple variables.Results: there were no cases of infection observed.There was one dislocation event in a patient who had undergone a cup revision and was noted to have an abductor tear at that time of surgery; this was treated with closed reduction with no further instability events.One patient was re-revisided during the study period; this patient had undergone cup revision that was subsequently re-revised due to aseptic loosening of the acetabular component, at 8 months post-operatively.Average length of stay (los) was 2.1 days.Multiple linear regression analysis identified a significant correlation between presence of an abductor injury, patient age , and pre-revision femoral head size.Conclusion: patients with abductor injury, larger femoral heads, and younger age are at risk for longer los.

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 CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17286350
• MDR Text Key: 318651704
• Report Number: 1818910-2023-13756
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• 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