MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/-3; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 06-2898

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

It was reported that patient's right hip was been revised due to leg length discrepancy.Update (b)(6) 2017: a review of the implant sheets provided found that the adm liner and not the mdm liner was explanted.

Event Description

It was reported that patient's right hip was been revised due to leg length discrepancy.Update 20 dec 2017: a review of the implant sheets provided found that the adm liner and not the mdm liner was explanted.

Manufacturer Narrative

An event regarding limb length discrepancy involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned 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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided and the device was not returned.Further information such as product evaluation, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/-3
• 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
• MDR Report Key: 7191429
• MDR Text Key: 97274474
• Report Number: 0002249697-2018-00151
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K993601
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 06-2898
• Device Lot Number: 3W5VXR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 61