MAUDE Adverse Event Report: DEPUY IRELAND 961610 S-ROM*SLEEVE PRX ZTT, 14B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550501
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Srom revision.Srom revision due to dislocation 5 years after initial surgery.Stem does not seem to have engaged with taper and had come loose.Sleeve well fixed and left in situ.Stem was revised to include a 36 neck option ad poly was exchanged for a 36/52 neutral cup with a 36 head.Patient stable post op.Relevant patient pre-existing conditions/ comorbidities: previous dysplastic hip with pelvic osteotomy.Doi: 5 years ago; dor: (b)(6) 2018 ; unknown hip.
Additional Manufacturer Narrative
Product complaint # = > pc-(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 IRELAND 961610; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7410652
• Report Number: 1818910-2018-56945
• Device Sequence Number: 11037122
• Product Code: LPH
• UDI-Device Identifier: 10603295175179
• UDI-Public: 10603295175179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: 06/30/2020
• Device Catalogue Number: 550501
• Device Lot Number: 8145991
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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: Required Intervention
• Patient Age: 34 YR