MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 16B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	521465
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	07/02/2018
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
Patient had femoral fracture, 4 mths post implantation.All components were removed and an implant from another company used.Doi: (b)(6) 2018; 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.Depuy considers the investigation closed at this time.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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7721814
• Report Number: 1818910-2018-65235
• Device Sequence Number: 13715617
• Product Code: LPH
• UDI-Device Identifier: 10603295170624
• UDI-Public: 10603295170624
• 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 Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 521465
• Device Lot Number: 8584021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/03/2018
• 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: 54 YR