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

Catalog Number	623-10-36G
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the x3 poly fit inside the trident acetabular cup, however the poly was consistently moving and did not snap into the cup.As a result, the poly would not stop rotating and was not able to be implanted.A new poly of the same size was opened, which fit the cup, and the surgery was completed without further incident.It was reported that a surgical delay of 5 minutes occurred (spent seating the poly).
Additional Manufacturer Narrative
Additional info: device returned.An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device noted the following: damage consistent with implantation process.Dimensional inspection & functional inspection:not performed as the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis of the returned device noted the following: damage consistent with implantation process, based on the given information no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 have been no other similar events for the lot referenced.Conclusions: material evaluation was completed and indicated the following comments: damage consistent with implantation process, based on the given information no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection and functional inspection were not performed as the reported device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Thus, the exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the x3 poly fit inside the trident acetabular cup, however the poly was consistently moving and did not snap into the cup.As a result, the poly would not stop rotating and was not able to be implanted.A new poly of the same size was opened, which fit the cup, and the surgery was completed without further incident.It was reported that a surgical delay of 5 minutes occurred (spent seating the poly).

• 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: 8471858
• Report Number: 0002249697-2019-01496
• Device Sequence Number: 1471579
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: 07613327039931
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: No Information
• Device Expiration Date: 01/20/2018
• Device Catalogue Number: 623-10-36G
• Device Lot Number: V80W7L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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: Other
• Patient Age: 70 YR