MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MAR LNR L 32MM+3MM 10 DEG; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1220-72-332
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	09/07/2021
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
This pc is to capture the medical record from (b)(6) 2021 note that the patient has dislocated 3 times and has instability.
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 MAR LNR L 32MM+3MM 10 DEG
• Common Device Name: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12525392
• Report Number: 1818910-2021-20965
• Device Sequence Number: 20120496
• Product Code: KWA
• UDI-Device Identifier: 10603295015918
• UDI-Public: 10603295015918
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 12/31/2024
• Device Model Number: 1220-72-332
• Device Catalogue Number: 122072332
• Device Lot Number: 9323945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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*CUP ACE,ZTT-2 L32,60DP+6; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,45 MM LG; S-ROM*SCREW,6.5MM DIA,50MM LG; S-ROM*SCREW.5.0MM DIA,40 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG; TOTAL HIP BALL 32MM +0; UNKNOWN DEPUY FEMORAL STEM; S-ROM*CUP ACE,ZTT-2 L32,60DP+6; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,45 MM LG; S-ROM*SCREW,6.5MM DIA,50MM LG; S-ROM*SCREW.5.0MM DIA,40 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG; TOTAL HIP BALL 32MM +0; UNKNOWN DEPUY FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 72