MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0526
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address metallosis, pain, alval lesion and osteolysis.Intraoperatively, there was a dark, blackish fluid, bone loss, minor corrosion outside of the morse taper area and osteolysis.Osteomyelitis was noted to be present on the proximal femur.Stem and acetabular components were noted to be well fixed.There was quite a bit of proximal femoral osteoclasis which exposed majority of the anterior portion of the sleeve.Despite this, the implant remained well fixed.Right hip revision indicates that the patient had undergone the left hip revision due to elevated metal ion levels.Primary surgery notes indicate that during the final impaction of the femoral sleeve, there was a slight calcar crack.A cerclage wire was placed around the crack.Doi: (b)(6) 2005; dor: (b)(6) 2017 (left hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9794544
• Report Number: 1818910-2020-06996
• Device Sequence Number: 19435789
• Product Code: LPH
• UDI-Device Identifier: 10603295175315
• UDI-Public: 10603295175315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 05/01/2010
• Device Model Number: 55-0526
• Device Catalogue Number: 550526
• Device Lot Number: 1903553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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: CUP 121722052/Z5CC91000; HEAD 136532000/1953563; LINER 121887352/1965164; SCREW 121720500/ZX7AX4000; SLEEVE 550526/1903553; STEM 523418/1914427
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR