MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0526
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/04/2021
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
Patient was revised due to painful left hip and loosening of the stem at bone to implant interface.Doi: (b)(6) 2003, dor: (b)(6) 2021.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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12360936
• Report Number: 1818910-2021-18521
• Device Sequence Number: 14437493
• Product Code: LPH
• UDI-Device Identifier: 10603295175315
• UDI-Public: 10603295175315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• 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): 08/04/2021

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: 55-0526
• Device Catalogue Number: 550526
• Device Lot Number: 1001847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 32IDX62OD; S-ROM HEAD FEMORAL COCR 32+0; S-ROM SLEEVE PRX ZTT, 18F-LRG; S-ROM STM STD,42 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 32IDX62OD; S-ROM HEAD FEMORAL COCR 32+0; S-ROM SLEEVE PRX ZTT, 18F-LRG; S-ROM STM STD,42 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91