MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3516
Medical Device Problem Codes	Fracture (1260); Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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.(b)(4).Occupation: attorney.
Event or Problem Description
Ppf and sticker sheets received.Ppf alleges metal wear, metallosis, elevated metal ions and fracture (component).
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.Additional narrative: udi: (b)(4).
Event or Problem Description
Pfs alleges pain, disfigurement, loss of mobility and loss of range of motion.
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 STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8373414
• Report Number: 1818910-2019-85855
• Device Sequence Number: 2229514
• Product Code: JDI
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2019

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: 09/30/2009
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Device Lot Number: 1235032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 04/14/2020
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/25/2019; 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 107