MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1035-40-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Litigation record received.Litigation alleges that the patient was diagnosed with fibroadipose tissue and focal synovium with chronic inflammation, hemosiderosis and metallosis.Doi: (b)(6) 2017.Dor: (b)(6) 2017.Right hip (second revision).
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.
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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SELF CENT HIP 40X28 RUST
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14336366
• Report Number: 1818910-2022-08435
• Device Sequence Number: 5337292
• Product Code: KWY
• UDI-Device Identifier: 10603295003304
• UDI-Public: 10603295003304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Expiration Date: 03/31/2022
• Device Model Number: 1035-40-000
• Device Catalogue Number: 103540000
• Device Lot Number: H73662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 NEUT 40IDX64OD.; DELTA CER HEAD 11/13 28MM +6.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX8MM.; PINN MULTIHOLE W/GRIPTION 64MM.; SELF CENT HIP 40X28 RUST.; SROM*STM ST,36+8L NK,18X13X160.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female