MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-54F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision due to pain involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual inspection, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: patient underwent revision surgery as described above.I am not able to fully confirm the event since i have no supporting evidence such as postoperative x-rays and an operative note.Regarding the root cause of this event, it is impossible to determine since there is no mention of any implant dysfunction, only that the patient had pain.Supporting documentation such as office notes and the work up for the painful joint would help determine root cause.Postoperative pain is multi factorial and may not be implant related.I certify that i have completed the medical risk assessment to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions: an event regarding revision due to pain involving trident shell was reported.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Catalog numbers and lot codes of other devices listed in this report: 626-00-46f, modular dual mobility insert, lot unknown.6260-9-228, 28mm +4 lfit v40 head, lot unknown.2030-65xx-1, unknown screw, lot unknown.1236-2-852, restoration adm x3 ins 28/52, lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "dr.Explanted a trident psl cluster cup, 1 torx bone screw, and a dual mobility construct consisting of a x3 poly liner with a 28mm metal femoral head.Information on the original surgery (hospital, physician, date) were not provided in any patient notes.The explanted items were kept by request of the hospital so they were not able to be collected and lot#¿s were unable to be obtained, either.After explanting the items, dr.Proceeded to implant a trident 2 tritanium multi hole cup with a 0º 36 x3 liner and a 36mm delta ceramic head." spoke to rep: patient's right hip was revised due to pain.Confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: TRIDENT PSL HA CLUSTER 54MM
• 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: 11746206
• Report Number: 0002249697-2021-00756
• Device Sequence Number: 4365520
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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 Model Number: 542-11-54F
• Device Catalogue Number: 542-11-54F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: 62 YR