MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX SPA, 16B; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	535362
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
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
The 16b reamer did not prepare the femur adequately for the 16b spoutless sleeve implant.The reaming was done twice, but the sleeve still could not be seated to where the reamer cleared.The sleeve was left proud by about 5mm.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 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 Manufacturer Narrative
Product complaint # = > (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 8889650
• Report Number: 1818910-2019-100981
• Device Sequence Number: 19586052
• Product Code: KWZ
• UDI-Device Identifier: 10603295172475
• UDI-Public: 10603295172475
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 535362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 09/23/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1