MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 06-2800

Device Problems Failure To Adhere Or Bond (1031); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Toxicity (2333); Injury (2348); Joint Dislocation (2374); Inadequate Osseointegration (2646)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Metallosis of a hip revision surgery.The head and stem were removed due to inter operative findings of loosening of the stem.We originally thought the stem/head combo could be preserved, but upon testing fixation, inadequate fixation was present and the stem was removed easily with flexible osteotomes.The patient was experiencing chronic dislocations due to insufficient construct integrity, which allowed the femoral head to "windshield wipe" within the hip joint.This movement was contributing to metal on metal interactions with the associated acetabular component leading to accelerated metallosis.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding dislocation involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: not performed as no devices were returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "the primary harm involved is wear, damage and loosening of tha implants 18 years status post implantation.Causation of these findings are consistent with reported chronic dislocation of this tha.No material or manufacturing defects were observed during the material analysis of the retrieved implants." device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation concluded that reported chronic dislocation was caused by wear, damage and loosening of the tha implants.No material or manufacturing defects were observed during the material analysis of the retrieved implants.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.Not returned.

Event Description

Metallosis of a hip revision surgery.The head and stem were removed due to inter operative findings of loosening of the stem.We originally thought the stem/head combo could be preserved, but upon testing fixation, inadequate fixation was present and the stem was removed easily with flexible osteotomes.The patient was experiencing chronic dislocations due to insufficient construct integrity, which allowed the femoral head to "windshield wipe" within the hip joint.This movement was contributing to metal on metal interactions with the associated acetabular component leading to accelerated metallosis.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/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: 5924836
• MDR Text Key: 53819295
• Report Number: 0002249697-2016-02835
• 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: 08/04/2016

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 Catalogue Number: 06-2800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR