MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3418

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 09/18/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient underwent a revision tkr for a failed primary hip (competitor product) on (b)(6) 2020.Patient received a s-rom modular stem as part of the revision surgery performed on (b)(6) 2020.The stem was undersized and has become loose over time, so was revised today and exchanged for a larger s-rom hip.Doi: (b)(6) 2020; dor: (b)(6) 2021 unknown side.

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.

Event Description

Additional information received indicated that the affected side was the right 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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12568407
• MDR Text Key: 274479620
• Report Number: 1818910-2021-21788
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171034
• UDI-Public: 10603295171034
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2021

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 Model Number: 52-3418
• Device Catalogue Number: 523418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/24/2021; 11/09/2021
• Supplement Dates FDA Received: 10/27/2021; 11/10/2021
• 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
• Treatment: DELTA CER HEAD 11/13 36MM +0; S-ROM*SLEEVE PRX ZTT, 18F-LRG; SROM*STM ST,36+8L NK,18X13X160; DELTA CER HEAD 11/13 36MM +0; S-ROM*SLEEVE PRX ZTT, 18F-LRG; SROM*STM ST,36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention
• Patient Sex: Male