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

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Nerve Damage (1979); Inadequate Osseointegration (2646); Thrombosis/Thrombus (4440)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: shi l, che g, huang y, yi m, kang p.Outcomes of total hip arthroplasty with a standard prosthesis for the affected hip in patients with poliomyelitis sequelae: a mid-term retrospective follow-up study.J orthop surg res.2023 mar 13;18(1):195.Doi: 10.1186/s13018-023-03697-6.Pmid: 36915109; pmcid: pmc10009972.Objective and methods: authors sought to analyze the mid-term outcomes of primary total hip arthroplasty on patients with poliomyelitis sequelae who underwent total hip arthroplasty (tha) from january 2008 to january 2018, due to severe pain and dysfunction of the affected hip.Clinical and radiographical outcomes, complications, and prosthesis survival rates were evaluated.All acetabular components were depuy pinnacle, and all femoral components were corail stem.The bearing surface was ceramic-on-ceramic in 11 hips, ceramic-on-polyethene in 20 hips, and ceramic-on-metal in one hip.Results: after follow-up, survey scores significantly improved.The abduction and flexion motions of the hip joint improved dramatically, and the visual analogue scale pain score decreased significantly.The leg length discrepancy was effectively corrected.Complications: intraoperative proximal femoral fractures occurred in seven hips, which were managed with cerclage wires.During follow-up, one patient experienced prosthetic dislocation from a fall (treated with closed reduction and lower extremity brace), one underwent revision surgery due to acetabular component loosening, two had osteolysis, four had heterotopic ossification, two experienced transient sciatic nerve palsy (from limb extension), and one had intermuscular vein thrombosis (treated with venous thrombolytic therapy).The prosthesis survival rate was 96.9% at 5 years postoperatively.No periprosthetic infection or post-op periprosthetic fractures occurred.Conclusion: total hip arthroplasty with standard prosthesis could be an effective treatment for hip arthropathy on the affected hip of patients with poliomyelitis sequelae, resulting in good clinical outcomes and few complications.

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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18874295
• MDR Text Key: 337314688
• Report Number: 1818910-2024-05518
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Date Manufacturer Received: 03/04/2024
• 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