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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Ppf and implant record received.Patient had an infection and dislocation after 1st revision.Doi: (b)(6) 2011.Dor: (b)(6) 2017, (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, 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 =the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 12495768
• Report Number: 1818910-2021-20481
• Device Sequence Number: 14222810
• Product Code: LPH
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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 Expiration Date: 11/30/2015
• Device Model Number: 56-3517
• Device Catalogue Number: 563517
• Device Lot Number: 3232229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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: S-ROM M HEAD 36MM +0; SROM STM ST,36+6L NK,11X16X150; ZIMMER BONE SCREW: 61357426/62506520; ZIMMER BONE SCREW:61560436/62506520; ZIMMER BONE SCREW:61674423:62506525; ZIMMER CUP:61460558/875705602; ZIMMER POLY LINER: 61652141/875101236; S-ROM M HEAD 36MM +0; SROM STM ST,36+6L NK,11X16X150; ZIMMER BONE SCREW: 61357426/62506520; ZIMMER BONE SCREW:61560436/62506520; ZIMMER BONE SCREW:61674423:62506525; ZIMMER CUP:61460558/875705602; ZIMMER POLY LINER: 61652141/875101236
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR