MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-36G
Medical Device Problem Code	Material Distortion (2977)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The surgeon reported that he attempted to impact the liner into the acetabulum cup which he had just placed into the pelvis.On impaction (with the correct liner impactor) the liner failed to seat correctly into the cup.The surgeon removed the liner to examine the problem more closely.On further inspection, the surgeon noticed the four indexing barbs which are circumferentially aligned around the rim of the polyethylene liner were not fully formed.Following this, the liner was placed aside and not used.Subsequently, a different liner was opened and implanted into the patient.No harm was caused to the patient from the faulty implant.There was a short surgical delay of 3 minutes while a new liner was opened.
Additional Manufacturer Narrative
Additional information: gender; unique identifier (udi) #; returned to manufacturer on; initial reporter type - other.An event regarding seating/ locking issue involving a trident liner was reported.The event was confirmed following a dimensional inspection of the returned trident liner.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the dimensional inspection dated 13 jul 2017.The report noted " extensive damage was observed on locking taper and outer rim, consistent with incorrect alignment with cup and potentially caused during the attempted implantation".Dimensional inspection: the device was inspected as per (b)(4) (ref.Attached inspection) and found to be dimensionally out of specification for the following : (b)(4).The report noted that the device was within dimensional specification at the time of release and the complaint was deemed not to be manufacturing related.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: there were no manufacturing issues noted during the dhr review and all devices was found to be dimensionally compliant at time of manufacture.However, the returned trident liner was inspected as per (b)(4) and found to be dimensionally out of specification.The exact cause of the event cannot be determined based on the information provided.Further information such as details of the shell and the operative report are needed to complete the investigation for determining root cause.No further investigation is possible at this time as insufficient information was received.If additional information becomes available the investigation will be reopened.
Event or Problem Description
The surgeon reported that he attempted to impact the liner into the acetabulum cup which he had just placed into the pelvis.On impaction (with the correct liner impactor) the liner failed to seat correctly into the cup.The surgeon removed the liner to examine the problem more closely.On further inspection, the surgeon noticed the four indexing barbs which are circumferentially aligned around the rim of the polyethylene liner were not fully formed.Following this, the liner was placed aside and not used.Subsequently, a different liner was opened and implanted into the patient.No harm was caused to the patient from the faulty implant.There was a short surgical delay of 3 minutes while a new liner was opened.

• Brand Name: TRIDENT 10° X3 INSERT 36MM 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: 6632148
• Report Number: 0002249697-2017-01812
• Device Sequence Number: 796960
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: (01)07613327039931(11)170118(17)220118(10)58399901
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 01/18/2022
• Device Model Number: 623-10-36G
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 58399901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 08/23/2017
• 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