MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3518
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter is 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
Unf and pinnacle medical records received.After review of medical records the patient was revised to address instability due to fall resulting to dislocation and pain.Operative note reported hip was found dislocated.There is a mild scratching on the trunnion and acetabular cup.Intra-operative mentioned, the constrained liner bent.Another liner was impacted.X-ray result confirmed the dislocation.Doi: (b)(6) 2018; dor: (b)(6) 2019; 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.

• 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: 10627908
• Report Number: 1818910-2020-21590
• Device Sequence Number: 2969262
• Product Code: JDI
• UDI-Device Identifier: 10603295178217
• UDI-Public: 10603295178217
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 07/31/2011
• Device Model Number: 56-3518
• Device Catalogue Number: 563518
• Device Lot Number: 2184850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: +12 X 36MM CERAMIC HEAD BALL; 52 X 36 MM POLYETHYLENE INSERT; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 52MM; SROM STM ST,30+4L NK,18X13X160; +12 X 36MM CERAMIC HEAD BALL; 52 X 36 MM POLYETHYLENE INSERT; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 52MM; SROM STM ST,30+4L NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR