MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA HIP STEM #8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6051-0830

Device Problems Mechanical Problem (1384); Connection Problem (2900); Naturally Worn (2988); Osseointegration Problem (3003)

Patient Problems Pain (1994); 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

An event regarding loosening involving a securfit stem was reported.The event was confirmed.Method & results: device evaluation and results: as per mar, biological fixation material was observed on the stem.Damage consistent with the explanation process was observed on the trunnion of the stem.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 material analysis indicated biological fixation material was observed on the stem.Damage consistent with the explanation process was observed on the trunnion of the stem.The medical assessment noted that 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.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 HIP STEM #8
• 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: 5924847
• MDR Text Key: 53821708
• Report Number: 0002249697-2016-02836
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982032
• 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: 04/30/2002
• Device Catalogue Number: 6051-0830
• Device Lot Number: 26460906
• 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: 04/24/1997
• 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