MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3420
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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
Asr medical records received.After review of medical records patient was revised to addressed metallosis.Corrosion was noted on the trunnion.The cup was removed without difficulty and came out with minimal bone.Some areas where the porous coating had been eroded by the presence of some retained stainless steel hardware from internal fixation of the acetabulum.Doi: (b)(6) 2006, dor: (b)(6) 2019, right 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 STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11640860
• Report Number: 1818910-2021-07518
• Device Sequence Number: 2988378
• Product Code: LWJ
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• 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: 2006
• 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): 03/23/2021

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: 03/31/2011
• Device Model Number: 52-3420
• Device Catalogue Number: 523420
• Device Lot Number: 2125367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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: ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; S-ROM*SLEEVE PRX ZTT, 20F-XXL; SROM*STM ST,36+8L NK,20X15X165; ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; S-ROM*SLEEVE PRX ZTT, 20F-XXL; SROM*STM ST,36+8L NK,20X15X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR