MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-60G
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not returned / not received.
Event or Problem Description
As reported: "doctor.Informed me of a patient done at another hospital by another surgeon that was referred to him by that surgeon.Patient complaint of pain."mri and bone scan consistent with particle disease".Surgery is scheduled for (b)(6) 2018.No other information is available.Doctor didn't tell me side.Another per will be filed.After surgery".Rep reported that this event is for patient's hip.Update 23-jul-2018: patient revised on (b)(6) 2018.As reported by rep: "necrotic fat and some fluid was aspirated after incision was made.Femoral stem was well fixed and anteverted appropriately.[surgeon] thinks the cup was loose.Removed the head and acetabulum along with one screw.A [competitor] multihole revision shell was inserted.A new femoral head was placed on the stem.Left side.No other information is available due to hospital policy".

• Brand Name: TRIDENT PSL HA CLUSTER 60MM
• 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: 7779600
• Report Number: 0002249697-2018-02518
• Device Sequence Number: 11092670
• Product Code: LPH
• UDI-Device Identifier: 04546540240538
• UDI-Public: 04546540240538
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 03/31/2021
• Device Catalogue Number: 542-11-60G
• Device Lot Number: 54944701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/13/2018
• 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: 75 YR
• Patient Weight: 99