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

Device Problems Mechanical Problem (1384); Fitting Problem (2183)

Patient Problems Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event 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.

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 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
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6559001
• MDR Text Key: 75007168
• Report Number: 0002249697-2017-01494
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327013450
• UDI-Public: (01)07613327013450(11)170103(17)220131(10)58263802
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 93 YR