MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 26MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 06-2600

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the doctor couldn't get the head to lock on the femoral component.New head was opened and implanted.

Manufacturer Narrative

An event regarding seating/locking issues involving a c-taper cocr lfit head 28mm/0 was reported.The event was not confirmed.Method & results: -device evaluation and results: a functional confirmed the head locked onto the stem after impaction.-medical records received and evaluation: a medical review was not performed because no records were provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event was not confirmed as a functional confirmed the head locked onto the stem after impaction.If further information becomes available, this investigation will be re-opened.

Event Description

It was reported that the doctor couldn't get the head to lock on the femoral component.New head was opened and implanted.

• Brand Name: C-TAPER COCR LFIT HEAD 26MM/0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5813183
• MDR Text Key: 50929611
• Report Number: 0002249697-2016-02404
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• 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: 06/27/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 06-2600
• Device Lot Number: 9X0X6H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2015
• 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: 92 YR