MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3191
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
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 srom stem broken as seen in preop xray.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Visual examination of the provided photographs and x-ray images confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: product code 523191, work order 7845768 was manufactured on 12-feb-2014.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: 1 nonconformance is associated with this lot: nr-0003125 was opened in relation to 0-12" height gauge ci058 that was found to be out of specification on scheduled calibration.The root cause for the gauge can be wear or damaged to the gauge.There is no correlation between this non-conformance and the failure mode of the complaint.Certificate of conformance review for (b)(4), product code 523191, work order 7845768 met specification.

• 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: 12373108
• Report Number: 1818910-2021-18759
• Device Sequence Number: 11746252
• Product Code: JDI
• UDI-Device Identifier: 10603295170853
• UDI-Public: 10603295170853
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 52-3191
• Device Catalogue Number: 523191
• Device Lot Number: 7845768
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: DELTA CER HEAD 11/13 32MM +0; S-ROM*SLEEVE PRX ZT HA 14D-LRG; S-ROM*STM STD,36NK,14X09X130; DELTA CER HEAD 11/13 32MM +0; S-ROM*SLEEVE PRX ZT HA 14D-LRG; S-ROM*STM STD,36NK,14X09X130
• Outcome Attributed to Adverse Event: Required Intervention