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

Catalog Number UNK HIP ACETABULAR CUP PINNACL

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

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Pain (1994)

Event Date 06/01/2018

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: sibia us, king pj.Minimum 5-year follow-up of articular surface replacement acetabular components used in total hip arthroplasty.Am j orthop (belle mead nj).2018 jun;47(6).Doi: 10.12788/ajo.2018.0048.Pmid: 29979802.Objective and methods: the articular surface replacement xl (asr-xl) metal-on-metal tha was recalled due to a higher than expected early failure rate.The purpose of this article was to evaluate the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up.A single-center, single-surgeon retrospective review was conducted for 32 implanted with the depuy synthes asr¿ xl acetabular hip system from december 2005 to november 2009.The thas included either a summit or trilock depuy femoral stem, though the actual number of each stem is unknown.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: asr xl (femoral, sleeve, cup), summit stem, trilock stem.Adverse event(s) and provided interventions associated with depuy devices: 20 unrevised constructs with elevated serum metal ions above 7 ppb.Revisions: 11 revisions to treat pain and 1 revision to treat pain and infection.The following are the intraoperative findings: 12 cases of elevated blood heavy metals above 7 ppb, 1 pseudotumor, 10 cases of loosened cups and femoral heads, 1 femoral head migration, 1 case of impingement captured as joint movement impairment, i revised patient received a pinnacle/summit construct which required an additional revision to an unknown tha to treat pain, metallosis, and extraskeletal ossification.

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: 17286574
• MDR Text Key: 318653289
• Report Number: 1818910-2023-13762
• 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: 07/11/2023
• 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