MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-50D
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "the cup was prepared for implanting by threading on the small magnetic bolt that is designed for the tritanium ii cup.After impacting the cup, [surgeon] tried to unscrew the bolt with zero success.This necessitated him removing the implanted cup and once again attempting to unscrew the bolt unsuccessfully.It took a few staff members using various instruments to dislodge the bolt from the cup.The surgeon indicated that the cup's dome hole threads had been compromised and asked for a second cup of the same size to be opened.A different bolt was used for this and the cup was impacted successfully".
Event or Problem Description
As reported: "the cup was prepared for implanting by threading on the small magnetic bolt that is designed for the tritanium ii cup.After impacting the cup, [surgeon] tried to unscrew the bolt with zero success.This necessitated him removing the implanted cup and once again attempting to unscrew the bolt unsuccessfully.It took a few staff members using various instruments to dislodge the bolt from the cup.The surgeon indicated that the cup's dome hole threads had been compromised and asked for a second cup of the same size to be opened.A different bolt was used for this and the cup was impacted successfully".
Additional Manufacturer Narrative
B1 corrected to product problem.B2 corrected to other serious (important medical events).Reported event: an event regarding a disassembly issue involving a trident shell was reported.The thread damage event was confirmed based on evaluation of the returned device.Method & results: device evaluation and results: visual inspection: implantation/explanation damage was observed on the threads of the shell, no material or manufacturing defects were observed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices 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.Conclusion: based on evaluation of the returned device it appears that the threads on the dome hole were damaged during implantation/explanation.The exact cause of the event could not be determined.Because insufficient information was provided.

• Brand Name: TRIDENTII TRITANIUM CLUSTER50D
• 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: 8699228
• Report Number: 0002249697-2019-02254
• Device Sequence Number: 2662852
• Product Code: LPH
• UDI-Device Identifier: 07613327344103
• UDI-Public: 07613327344103
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• 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): 08/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 702-04-50D
• Device Lot Number: 69928201A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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; Other; Required Intervention