MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3514
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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
Medical records received.After review of medical records, the patient represent with increase pain and discomfort.Cobalt and chromium levels were elevated, a metal subtraction mri showed a large fluid collection, consisted with adverse tissue reaction.The patient was then revised for failed right metal on metal tha.Operative notes reported that there was about 60 cc of graying fluid emanated from what appeared to be a pseudotumor consistent with adverse tissue reaction.Some necrotic appearing material was debrided.There was some evidence of membrane formation at the metal interfaces consistent more with metal on metal reaction vs polyethylene osteolysis.There was a significant amount of blackish corrosion at the female portion of the femoral head.There was some corrosion on the taper.Doi: (b)(6) 2009; dor: (b)(6) 2019, right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the device manufacturing records found no related deviation or anomalies.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: this manufacturing record (dhr) was reviewed previously.(b)(4), no related deviations or anomalies identified.Device history review: this manufacturing record (dhr) was reviewed previously.(b)(4), no related deviations or anomalies identified.H10 additional narrative: added: e3; corrected: e1.E3 initial reporter occupation: lawyer.

• 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: 10599812
• Report Number: 1818910-2020-21056
• Device Sequence Number: 3205244
• Product Code: JDI
• UDI-Device Identifier: 10603295178187
• UDI-Public: 10603295178187
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2010
• Device Model Number: 56-3514
• Device Catalogue Number: 563514
• Device Lot Number: 1975958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 11/04/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/05/2020; 11/04/2020
• 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: PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.; S-ROM M HEAD 36MM +9.; S-ROM*SLEEVE PRX ZTT, 14B-LRG.; PINN CAN BONE SCREW 6.5 MMX25 MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54 MM; S-ROM M HEAD 36 MM +9; S-ROM*SLEEVE PRX ZTT, 14B-LRG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR