MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-28D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the trident x3 liner was not fitted in the trident cup.Therefore, the liner was changed with a new one and the operation was successful.
Additional Manufacturer Narrative
An event regarding alleged "size/fit issue" involving a trident liner was reported.The event was not confirmed.Examination of the returned device with material analysis engineer indicated that there was no material integrity issue.No damages observed on the device.However, evidence of use was observed on the insert.No medical records were received for review with a clinical consultant.All devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The event was not confirmed and the root cause of the event could not be determined.The returned device was returned in used condition and therefore will not meet dimensional specifications.No damages observed on the device.No further investigation is required.If additional relevant information becomes available this investigation will be reopened.
Event or Problem Description
It was reported that the trident x3 liner was not fitted in the trident cup.Therefore, the liner was changed with a new one and the operation was successful.

• Brand Name: TRIDENT 0° X3 INSERT 28MM 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: 6460582
• Report Number: 0002249697-2017-01138
• Device Sequence Number: 13598274
• Product Code: LPH
• UDI-Device Identifier: 07613327039382
• UDI-Public: (01)07613327039382(11)151203(17)201231(10)M73V0V
• Combination Product (Y/N): N
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: 12/31/2020
• Device Catalogue Number: 623-00-28D
• Device Lot Number: M73V0V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/15/2017
• 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
• Patient Age: 73 YR
• Patient Weight: 45