MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-44F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.Wear was confirmed by the explanation photos provided.Method & results: product evaluation and results: the device was not returned but one explant photo was provided.The photo shows the outer surface of the liner.There is some biological material present.There are some circular indentations visible along with one small perforation of the liner and one larger, through hole.Medical records received and evaluation: provided x-rays, explant photos and intraoperative photo were reviewed by a clinician who gave the following comment: provided x-ray showed dissociated components, photographs showed metallosis and trunnion deformities, need operative reports, histopathology reports, serial x-rays, office reports and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, histopathology reports, serial x-rays, office reports and examination of explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's right hip was revised due to disassociation.Intra-operatively, pseudotumor was reported with an excessive amount of black tissue observed.The trunnion was found to be worn down and the liner was worn through in at least 2 places.The shell was well-fixed and not revised.Patient was revised to a restoration modular stem construct with a 28 +8 metal head.2.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• 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: 8222820
• Report Number: 0002249697-2019-00060
• Device Sequence Number: 207272
• Product Code: LPH
• UDI-Device Identifier: 07613327025422
• UDI-Public: 07613327025422
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: 03/31/2013
• Device Catalogue Number: 623-00-44F
• Device Lot Number: 5PPMEE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 01/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 90