MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30 NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3292

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2021

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 stated that original implant date unknown.This patient had her left hip replaced by a surgeon approximately 12 years ago.The patient was doing well until recently where she was experiencing some pain and discomfort in her hip.She went to office to see dr.(b)(6), xrays look unremarkable but her labs indicated she had elevated cocr levels.Dr.(b)(6) scheduled the patient for a thr as he suspected that trunion and metal hip ball were producing metal debris.During the surgery the neutral pinnacle liner, metal femoral hip ball, and the 16x11 30 std neck srom stem were explanted.The srom sleeve and pinnacle acetabular cup were left in situ.The srom stem had damage or trunionosis on the neck as well as the inner taper of the metal femoral hip ball.A new srom stem, pinnacle liner, and ceramic femoral hip bal were implanted.I do not have the lott # information for the implants left in situ.I do not have the lot # for the 32mm metal hip ball that was explanted.Doi: 12 years ago, dor: (b)(6) 2021, left 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: in a complaint database search no other reports of any kind were identified over the previous five year period.It is difficult to conclude there was any error in manufacture or material after approximately 12 years implanted prior a need for revision.A manufacturing records evaluation (mre) was not performed.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11332178
• MDR Text Key: 231971266
• Report Number: 1818910-2021-03054
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295170976
• UDI-Public: 10603295170976
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52-3292
• Device Catalogue Number: 523292
• Device Lot Number: 3181142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 32MM + 3 METAL COCR FEMORAL HIP BALL; ALTRX NEUT 32IDX50OD; 32MM + 3 METAL COCR FEMORAL HIP BALL; ALTRX NEUT 32IDX50OD
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 67