MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; IMPLANT

Catalog Number 690-00-28F

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with a dislocated hip and disassociated acetabular insert (constrained liner).Right hip was revised to an mdm construct.Stem was a depuy cemented stem and was well fixed.No delay in surgery.Sales rep could not confirm if prior revision was of stryker product.

Manufacturer Narrative

An event regarding a dissociated constrained liner was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection confirmed the event.The metal liner was dissociated from the uh1 poly.Damage on the poly suggested impingement between the stem and the liner.-medical records received and evaluation: not performed as no patient medical records were provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because no patient medical records were provided for review.It was noted that the device was implanted with a competitor head and stem combination.It is possible this mixed-manufacturer combination resulted in impingement between the devices.No further conclusions can be made without additional medical records.If additional information become available, this investigation will be reopened.

Event Description

Patient presented with a dislocated hip and disassociated acetabular insert (constrained liner).Right hip was revised to an mdm construct.Stem was a depuy cemented stem and was well fixed.No delay in surgery.Sales rep could not confirm if prior revision was of stryker product.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5010639
• MDR Text Key: 23271139
• Report Number: 0002249697-2015-02698
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 690-00-28F
• Device Lot Number: MKTW42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2012
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 63