MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-01-52E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding shell malposition and rom involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.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: could not be performed as lot code information was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right hip was revised due to dislocation, subluxation and cup impingement.Intra-operatively, it was observed that the shell was well-fixed but malpositioned, the lip of the liner was found to be grooved, worn, and cracked, and mild wear debris was found in the head-trunnion interface.A trident hemispherical cluster hole shell, 10° e trident liner, and 36 +5 v40 lfit head were revised to a tritanium revision shell with 4 screws, a 40 liner, and a 40 metal head.The accolade i stem was well-fixed with the trunnion in good condition and was not revised.
Event or Problem Description
It was reported that the patient's right hip was revised due to dislocation, subluxation and cup impingement.Intra-operatively, it was observed that the shell was well-fixed but malpositioned, the lip of the liner was found to be grooved, worn, and cracked, and mild wear debris was found in the head-trunnion interface.A trident hemispherical cluster hole shell, 10° e trident liner, and 36 +5 v40 lfit head were revised to a tritanium revision shell with 4 screws, a 40 liner, and a 40 metal head.The accolade i stem was well-fixed with the trunnion in good condition and was not revised.
Additional Manufacturer Narrative
Reported event: an event regarding shell malposition and rom involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection visual inspection was performed as part of the material analysis report (mar), dated 29 mar 2019.This inspection indicated.[.] biological fixation was observed on the shell, [.].Damage was observed on the distal surface of the shell, consistent with contact against a hard object -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: the exact cause of the event could not be determined because insufficient information was provided.¿ additional information including , operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 52MM
• 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: 8347692
• Report Number: 0002249697-2019-01075
• Device Sequence Number: 16623150
• Product Code: LPH
• UDI-Device Identifier: 07613153073086
• UDI-Public: 07613153073086
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2009
• Device Catalogue Number: 502-01-52E
• Device Lot Number: 11418701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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; Required Intervention
• Patient Weight: 77