MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-40E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the product history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: trident 0 deg insert 40mm; cat#623-00-40e; lot#3v1jk5.Delta un.Fem hd 40mm r40 16/18; cat#6519-1-040; lot#54057205.Uni adaptor sleeve c taper ti; cat#19-0005t; lot#42142604.Secur-fit arc/ha collar stem#9; cat#s-2337-hf09; lot#k31mjd.Trident psl ha cluster 52mm; cat#542-11-52e; lot#jd5mld.6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#530med.6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#wtpmed.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Update per medical review: on an (b)(6) 2016 office visit the patient was noted to be ambulating with pain and was to return in six months.
Additional Manufacturer Narrative
An event regarding pain involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: on an november 16, 2016 office visit the patient was noted to be ambulating with pain and was to return in six months.¿ ¿delay of more than a month from a radiographic diagnosis of fractured ceramic liner to revision surgery resulted in marked fragmentation of the ceramic liner and dispersal of multiple small fragments (reported under another pi), making it difficult to completely remove all the particles.Revising to a metallic head allowed for the retained ceramic fragments to erode the cobalt-chrome surface elevating the blood ion level to potentially toxic levels (reported under another pi).Subsequent debridement and change to a ceramic/poly bearing resulted in the decreased blood ion levels.No adequate documentation of the "fall" that apparently resulted in the liner fracture is available for review.Examination of the explanted components and review of the surgical pathology slides would be helpful in evaluating this case.¿ -product history review: there have been no other events for this lot.-complaint history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Conclusions: the event for pain was confirmed but the root cause could not be determined.A review of the provided records by a clinical consultant indicated that through november 16, 2016 office note was the last office not provided for review.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
Update per medical review: on an (b)(6) 2016 office visit the patient was noted to be ambulating with pain and was to return in six months.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7890624
• Report Number: 0002249697-2018-02972
• Device Sequence Number: 19291950
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 623-00-40E
• Device Lot Number: 3V1JK5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 154