MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32G
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During surgery the plastic liner popped loose.This was a plastic liner used with trident.The surgeon couldn¿t tell if he was responsible or malfunctioning.It happened when he was about to trial the hip.A new liner was inserted and the operation continued.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.The returned part was visually inspected by support staff and extensive damage was observed on both the chamfer of the b radius and the taper angle located behind the outer sphere.A dimensional inspection was performed on the device.The following was noted: the returned device was re-inspected and found to be failing for "taper angle" above its respective upper tolerance and the q dimension (centre point of the inner b radius) above its respective upper tolerance.A review of the original dhr confirmed that the taper angle and q dimension of the returned device were in specification at the time of manufacture.During the original in-process inspection, as per igs requirements, the taper angle feature and q dimension are checked on a coordinate measuring machine (cmm) on one part of the original batch of 18 parts.It is likely that the assembly of the liner during surgery resulted in the damage observed on the part leading to the taper angle and q dimension going out of specification.The failure of these features and the damage observed on the inner and outer sphere are deemed to be consistent with the attempted implantation of the liner with the trident product.Conclusion: the complaint is deemed not to be manufacturing related.A review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.There were no other events for the lot and sterile lot provided.The inspection of the device concluded the following: the failure of these features and the damage observed on the inner and outer sphere are deemed to be consistent with the attempted implantation of the liner with the trident product.The complaint is deemed not to be manufacturing related.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report as well as patient history are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as 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
During surgery the plastic liner popped loose.This was a plastic liner used with trident.The surgeon couldn¿t tell if he was responsible or malfunctioning.It happened when he was about to trial the hip.A new liner was inserted and the operation continued.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• 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: 7299289
• Report Number: 0002249697-2018-00553
• Device Sequence Number: 19071907
• Product Code: LPH
• UDI-Device Identifier: 07613327039870
• UDI-Public: 07613327039870
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 623-10-32G
• Device Lot Number: 60915501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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