MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563518
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); Not Applicable (3189)
Date of Event	03/05/2005
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.An attorney.
Event or Problem Description
Litigation papers allege: patient experienced severe pain, discomfort, and inflammation in the leg, a popping and clicking sound in the hip; the sensation that the implant is unstable and will give out; inability to walk moderate or long distances; inability to sleep on patient's side without severe pain; inability to sit for moderate to long periods of time; metallosis; cobalt-chromium metal toxicity; infection; and other complications.Ppf alleges loosening of cup, metal wear and metallosis.It was also indicated in the ppf that cup, liner, head and stem were revised.Doi: (b)(6) 2005; dor: (b)(6) 2005; (left hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7780971
• Report Number: 1818910-2018-66569
• Device Sequence Number: 1757894
• Product Code: JDI
• UDI-Device Identifier: 10603295178217
• UDI-Public: 10603295178217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: 04/24/2008
• Device Catalogue Number: 563518
• Device Lot Number: 1099261
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/21/2019
• 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: 47 YR