MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 2051-2046

Device Problems Failure To Adhere Or Bond (1031); Degraded (1153); Metal Shedding Debris (1804); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

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

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

An event regarding wear involving a securfit shell was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis report was performed that concludes "the shell and insert had damaged consistent with cyclic contact against a hard object.The femoral head was not returned.No material or manufacturing defects were observed on the surfaces examined." -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: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: 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.As per mar it is concluded that shell was damaged that is consistent with cyclic contact against a hard object.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 additional information become available, this investigation will be reopened.

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: SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 5924837
• MDR Text Key: 53818879
• Report Number: 0002249697-2016-02834
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942900
• 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

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2000
• Device Catalogue Number: 2051-2046
• Device Lot Number: 17643902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/1995
• 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