MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3517
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2021
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
Hip revision to remove broken srom and patient report of pain.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided photograph 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 563517 work order (b)(4) went through gen label step on 01-apr-2015.(b)(4) parts were manufactured per specification and all raw materials met specification.No scrap parts found associated with lot 8090932.No ncs (non-conformances) found associated with lot 8090932.Certificate of compliance for lot 7123084 was reviewed as part of this dhr review.No deviations found associated with lot 7123084.

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• 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: 11670674
• Report Number: 1818910-2021-07962
• Device Sequence Number: 3050032
• Product Code: LPH
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 56-3517
• Device Catalogue Number: 563517
• Device Lot Number: 8090932
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 06/21/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/22/2021
• 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: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; EA DELTA CER INSERT 36IDX52OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 52MM; S-ROM*SLEEVE PRX ZTT, 16B-LRG
• Outcome Attributed to Adverse Event: Required Intervention