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

Catalog Number 6942-7-065

Device Problems Fitting Problem (2183); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event 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.

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 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
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7938396
• MDR Text Key: 123525573
• Report Number: 0002249697-2018-03222
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327013467
• UDI-Public: 07613327013467
• Combination Product (y/n): N
• PMA/PMN Number: K992570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR