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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Clinical notification received for revision of left total hip to address metallosis of the femur and acetabulum.Date of implantation: (b)(6) 2002; date of revision: (b)(6) 2020; (left hip).Treatment: revision of the metal head and metal liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided patient x-ray images have been reviewed.There is nothing indicative of a product problem identified.It was not possible to identify a root cause for the problems experienced using the provided images.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 manufacturing or material 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: 10931674
• Report Number: 1818910-2020-25930
• Device Sequence Number: 11661294
• Product Code: LWJ
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K910664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• 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): 11/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 52-3420
• Device Catalogue Number: 523420
• Device Lot Number: 1024815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; S-ROM M HEAD 36MM +0; S-ROM*SLEEVE PRX ZTT, 20D-SML; SROM*STM ST,36+8L NK,20X15X165; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; S-ROM M HEAD 36MM +0; S-ROM SLEEVE PRX ZTT, 20D-SML; SROM STM ST,36+8L NK,20X15X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83