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

Catalog Number	550501
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/10/2019
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
The primary surgery was performed on (b)(6) 2007 on the patient¿s right hip joint via tha.It was reported that the revision surgery was performed on (b)(6) 2019 by replacing the head (p/n: 1521900579), the liner (p/n: 124148000), the stem (p/n: 900526210) with the sleeve (p/n: 550501) due to looseness, breakage of the stem, thigh pain caused by sinking of the stem.The surgery was completed, and it was unknown whether there was a surgical delay or not.Doctor's view: size mismatch.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9140346
• Report Number: 1818910-2019-107006
• Device Sequence Number: 1825239
• Product Code: LPH
• UDI-Device Identifier: 10603295175179
• UDI-Public: 10603295175179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/28/2019
• 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: 72 YR