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

Model Number	502-01-52E
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the patient was revised due to dislocation.
Additional Manufacturer Narrative
Corrected data: device not returned.An event regarding dislocation involving a ceramic head & trident liner was reported.It was confirmed that the trident shell was revised.Conclusion: method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated 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.
Event or Problem Description
It was reported that the patient was revised due to dislocation.

• 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: 6504508
• Report Number: 0002249697-2017-01304
• Device Sequence Number: 16146880
• Product Code: LPH
• UDI-Device Identifier: 07613153073086
• UDI-Public: (01)07613153073086(11)160603(17)210630(10)55882002
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: 06/30/2021
• Device Model Number: 502-01-52E
• Device Catalogue Number: 502-01-52E
• Device Lot Number: 55882002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70