MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S-ROM*SLEEVE PRX ZTT, 22B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	521425
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Inadequate Osseointegration (2646); Test Result (2695)
Date of Event	12/05/2006
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Complaint description: litigation alleges the patient suffers from pain, discomfort, immobility, inflammation and high levels of chromium and cobalt.Update ad may 29, 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.Ppf alleges infection requiring iv antibiotics and loosening of stem.Updated product and lot number of insert (121887356/2136865), head ( 136531000/2193018), stem ( 523422/2160316), cup (121722056/a5wfx1000).
Additional Manufacturer Narrative
Pc-(b)(4).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 ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7698176
• Report Number: 1818910-2018-64678
• Device Sequence Number: 1618475
• Product Code: LPH
• UDI-Device Identifier: 10603295170600
• UDI-Public: 10603295170600
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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 Catalogue Number: 521425
• Device Lot Number: 1811741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: Other
• Patient Age: 56 YR