MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	6942-7-065
Medical Device Problem Codes	Fitting Problem (2183); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Primary procedure, hip.It was reported the unitrax c-taper sleeve would not stay on the stem when impacted on.Head remained impacted on the sleeve.The construct was removed and a c-taper lfit head was implanted instead.There was a surgical delay of approximately 10 minutes.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving a hip sleeve was reported.The event was not confirmed.Dimensional & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis: material analysis was not performed due to the nature of the event medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Primary procedure, hip.It was reported the unitrax c-taper sleeve would not stay on the stem when impacted on.Head remained impacted on the sleeve.The construct was removed and a c-taper lfit head was implanted instead.There was a surgical delay of approximately 10 minutes.

• Brand Name: UNITRAX C-TAPER SLEEVE +0MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7938396
• Report Number: 0002249697-2018-03222
• Device Sequence Number: 1346287
• Product Code: KWL
• UDI-Device Identifier: 07613327013467
• UDI-Public: 07613327013467
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K992570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 64998703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 69 YR