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

Catalog Number UNK HIP ACETAB CUP PINN

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 05/06/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: article entitled ¿a simple technique to remove an incarcerated ceramic liner in revision hip arthroplasty¿ written by binay gurung, mbc, owais a.Shah, mbbs, thomas c.Edwards, mbbs, irrum afzal, panagiotis d.Gikas, mbbs, phd, md, and richard e.Field, phd published in arthroplasty today may 6, 2023.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.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

Article entitled ¿a simple technique to remove an incarcerated ceramic liner in revision hip arthroplasty¿ written by binay gurung, mbc, owais a.Shah, mbbs, thomas c.Edwards, mbbs, irrum afzal, panagiotis d.Gikas, mbbs, phd, md, and richard e.Field, phd published in arthroplasty today may 6, 2023 was reviewed.55-year-old female had a right tha placed in (b)(6) 2007 for osteoarthritis secondary to severe congenital dysplasia.Pinnacle cup with 4 screws, ceramic head and liner, and corail stem was placed.12 years later she suffered deterioration with progressive loss of movement and increasing pain.Mri showed 2 screws protruding into the pelvis, with 1 in the belly of the iliacus muscle.The scan also showed that the acetabular component was positioned in 25 degrees anteversion and 61 degrees of inclination.The patient underwent a revision.The femoral stem was well fixed and retained.The femoral head and liner were revised with no allegation.Depuy implants were placed at revision.

• 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: 18021477
• MDR Text Key: 326734737
• Report Number: 1818910-2023-21842
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETAB CUP PINN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/27/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention