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

Catalog Number	521485
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/06/2012
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.
Event or Problem Description
(b)(4).Litigation alleges that patient experienced hip pain, causing difficulty ambulating and sleeping.Additionally, it is alleged that implant is releasing metal ions into patient's body.Update dec 05, 2017: pfs and medical records received.In addition to what were previously alleged, pfs alleges device failure resulting to injuries.After the review of medical records for mdr reportability, it was stated that the patient was revised to address wear and femoral component loosening.Clinical notes reported of pain, discomfort, restricted active and passive range of motion, antalgic gait and radiographic criteria consistent with loosening of his hip.Laboratory result for cobalt was below 7ppb.Added stem and sleeve impacted products.Doi: (b)(6) 2007; dor: (b)(6) 2012; left hip.
Additional Manufacturer Narrative
Udi: (b)(4).
Event or Problem Description
In addition to what were previously alleged, ppf alleges metal wear and metallosis.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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: 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, 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: 7160021
• Report Number: 1818910-2018-50106
• Device Sequence Number: 10779011
• Product Code: MRA
• UDI-Device Identifier: 10603295170648
• UDI-Public: 10603295170648
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 01/02/2012
• Device Catalogue Number: 521485
• Device Lot Number: 2295652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/28/2018; 12/09/2019
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/01/2019; 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 97