MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-46D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.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.
Event or Problem Description
It was reported via e-mail from sales representative that the dr.Surgically implanted and did a left hip revision due to loose cup.
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: no medical information was received for review with the clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar relevant events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined as sufficient information was not provided.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
It was reported via e-mail from sales representative that the dr.Surgically implanted and did a left hip revision due to loose cup.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 46MM
• 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: 6559883
• Report Number: 0002249697-2017-01507
• Device Sequence Number: 533381
• Product Code: LPH
• UDI-Device Identifier: 04546540240460
• UDI-Public: (01)04546540240460(11)161025(17)211031(10)57429302
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 07/11/2017

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: 10/31/2021
• Device Model Number: 542-11-46D
• Device Catalogue Number: 542-11-46D
• Device Lot Number: 57429302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/11/2017
• 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: 78 YR
• Patient Weight: 77