MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-33-000

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

Patient Problems Cyst(s) (1800); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Synovitis (2094)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).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

Clinical notification received for revision due to infection.Date of implant: (b)(6) 2008.Date of revision: (b)(6) 2022.(left hip).Treatment: revision; head and liner were revised.

Event Description

On (b)(6) 2008, patient received an uncemented left metal-on-metal total hip replacement with s-rom femur and pinnacle cup mom to address osteoarthritis.There were no reported complications.On (b)(6) 2022, patient had both the right and the left total hips revised to address hematogenous sepsis, fluid collections in both hips, acute pain and synovitis of the left hip, and chronic adverse reaction to metal debris of the right hip.The left hip also presented with gross pus, but in this case the rotators and capsule were still intact, there was no evidence in the left hip of chronic adverse reaction to metal debris.Cup and stem were well-fixed, with good positions in both cases, so only the head and metal liner were exchanged for polyethylene liner and metal head.Hip was well irrigated and debrided for treatment of the infection.

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, h4, h6 (clinical and impact codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: S-ROM M HEAD 36MM +6
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16223697
• MDR Text Key: 307891245
• Report Number: 1818910-2023-01711
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033509
• UDI-Public: 10603295033509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-33-000
• Device Catalogue Number: 136533000
• Device Lot Number: 2645602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/27/2023; 02/10/2023
• Supplement Dates FDA Received: 02/07/2023; 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2008
• 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
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +6; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White