MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tinnitus (2103); Swelling/ Edema (4577)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.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
Litigation and medical records received.Litigation alleges pain lump on buttocks, frequent loss of balance causing several falls, severe tinnitus, metallosis and psuedotumor.After review of medical records, the patient was revised due to metal on metal reaction.Operative notes reported that there was a small amount of pseudotumor seen posteriorly.There was abundant fluid in the joint.The trunnion had some slight black residue.Doi: (b)(6) , 2008 dor: (b)(6) , 2021 right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A provided photograph has been reviewed and is presumably the explanted devices within biohazard packaging.The devices themselves are not visible and the photo does not at all aid in this investigation.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: SUMMIT POR TAPER SZ3 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12143905
• Report Number: 1818910-2021-14876
• Device Sequence Number: 4169648
• Product Code: LPH
• UDI-Device Identifier: 10603295060048
• UDI-Public: 10603295060048
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 07/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 1570-11-090
• Device Catalogue Number: 157011090
• Device Lot Number: C41GC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/08/2021
• 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: ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT POR TAPER SZ3 HI OFF; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT POR TAPER SZ3 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR