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

Model Number	540-11-46D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Weakness (2145); Injury (2348)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that 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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: trident 0 deg x3 insert 32mm head, 623-00-32d, mnl7re; delta v-40 ceramic head 32/0, 6570-0-132, (b)(4).It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to pain and weakness in the hip.The rep reported that there were no allegations against the implants and that patient's soft tissue problems were the primary cause.The patient's shell, head and liner were revised.Rep provided the surgeon notes, office visit notes, and the primary usage sheet and reported that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT PSL HA SOLID BACK 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• MDR Report Key: 9868290
• Report Number: 0002249697-2020-00586
• Device Sequence Number: 10902906
• Product Code: LPH
• UDI-Device Identifier: 04546540237804
• UDI-Public: 04546540237804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: 04/30/2019
• Device Model Number: 540-11-46D
• Device Catalogue Number: 540-11-46D
• Device Lot Number: 471751001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/23/2020
• 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: 72 YR
• Patient Weight: 162