MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the surgeon informed the sales consultant that he had performed this patient's initial surgery about 10-11 years prior, exact date unknown.He was unable to pull up the operative note to give me an exact date.This patient suffered a hip dislocation that was believed to have happened several months prior.This patient suffers from cerebral palsy and is a bed bound patient.This patient also unfortunately had an ulcer on their hip that went down into the joint space.Dr.Decided this patient's best option was unfortunately to remove the implants and perform a girdlestone procedure.Once implants were properly removed a thorough debridement was performed of their hip and the closing process began.Doi: 10 to 11 years prior, dor: (b)(6) 2021, affected side: left hip.
Additional 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 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 history record (mre) review, was not possible because the required lot code was not provided.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11686664
• Report Number: 1818910-2021-08199
• Device Sequence Number: 2935678
• Product Code: JDI
• UDI-Device Identifier: 10603295170860
• UDI-Public: 10603295170860
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 52-3192
• Device Catalogue Number: 523192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 32IDX48OD; DELTA CER HEAD 11/13 32MM +0; PINN SECTOR W/GRIPTION 48MM; UNK HIP FEMORAL SLEEVE SROM; ALTRX NEUT 32IDX48OD; DELTA CER HEAD 11/13 32MM +0; PINN SECTOR W/GRIPTION 48MM; UNK HIP FEMORAL SLEEVE SROM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR