MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-352

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent total hip arthroplasty where a summit stem with a pinnacle sector cup with an ultimate metal liner was used.The surgeon who revised this hip couldn¿t recall how long ago the patient had his original surgery.Both the stem and cup were well fixed.The surgeon removed the liner and replaced it with a neutral altrx liner and a ts ceramic head.The surgeon stated pt had developed elevated metal ion count.Doi: 2014, dor: (b)(6) 2021, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Questions: a.Can you please confirm if the patient had a previous revision that involves depuy products? if yes, please provide product details, or if it was previously reported kindly provide a complaint number.B.We are required to enter the femoral stem information when high ions are alleged even if the stem was not revised.Can you please provide the product/lot details for the stem? answer: this patient underwent revision surgery on (b)(6) 2021 for the same reason on his right side mdr 241445.This mdr referenced mistakenly references the right side again but should of been marked left side.No information was gathered on the stem or cup.There was no patient harm and dr (b)(6) declined to give any additional information.Mdr 241445 captured in (b)(4) as patient developed a pseudo tumor in his hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot - a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12278599
• MDR Text Key: 265143002
• Report Number: 1818910-2021-17082
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1218-87-352
• Device Catalogue Number: 121887352
• Device Lot Number: 2363320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +8.5; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT STEM; ARTICULEZE M HEAD 36MM +8.5; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 83