MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE -3MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Catalog Number	6942-7-060
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported by the sales representative via phone that during a primary surgery for a fractured hip, that the taper head would not lock onto the stem.The physician tried 3 times.The physician used a bipolar head the same size and it worked.
Additional Manufacturer Narrative
An event regarding alleged "seating/locking issues" involving a unitrax c-taper sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in used condition.Review of the device with a material analysis engineer indicated "damage consistent with in-service use was observed on the sleeve.In-service use can potentially affect the dimensions of the product." a dimensional inspection was performed on the returned device and found the device to be within specifications.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause could be determined.Review of the device with a material analysis engineer indicated "damage consistent with in-service use was observed on the sleeve.In-service use can potentially affect the dimensions of the product." however, a dimensional inspection was performed on the returned device and found the device to be within specifications.
Event or Problem Description
It was reported by the sales representative via phone that during a primary surgery for a fractured hip, that the taper head would not lock onto the stem.The physician tried 3 times.The physician used a bipolar head the same size and it worked.

• Brand Name: UNITRAX C-TAPER SLEEVE -3MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6559001
• Report Number: 0002249697-2017-01494
• Device Sequence Number: 13486288
• Product Code: KWL
• UDI-Device Identifier: 07613327013450
• UDI-Public: (01)07613327013450(11)170103(17)220131(10)58263802
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K992570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 01/31/2022
• Device Catalogue Number: 6942-7-060
• Device Lot Number: 58263802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/13/2017
• 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