MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-48D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
Event or Problem Description
Mps reported robot issues.Mps reported reaming through medial wall and other issues.As reported via complaint form: after impaction, 48 cup would not stick.Surgeon indicated that posterior wall may have been reamed through.Surgical delay = 15 minutes.Case completed manually.Case type / application: tha 4.0.Update: additional information received from mps: "the surgeon indicated that she did not notice the posterior medial wall having damage until after cup impaction.Another surgeon who helped her with the repair/augment stated that he believed it may have been caused during cup impaction in combination with a thin medial wall as opposed to the reaming portion.".
Additional Manufacturer Narrative
Reported event: an event regarding patient factors involving a trident shell was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: this inquiry reports that the surgeon found damage to the posterior/medial wall of the acetabulum after impacting the component.The surgeon and her assistant postulated that it occurred either during the reaming process or upon impaction of the cup.I cannot confirm that this event took place since i have no objective evidence that the wall was compromised.No imaging is supplied to corroborate the event.Regarding the possible root cause of this event, if it did happen, the cause would be multifactorial.It is the surgeon¿s responsibility to review and approve the surgical plan before proceeding.Additionally, as the reaming progresses, the depth and amount of bone remaining is readily seen.Any deviation from the pre-operatively plan would be flagged with red within the acetabulum.Theoretically there could have been a change in the proposed plan but i am not sure if that is possible without mps input.I would also note that a pre-operative plan of 23 degrees of anteversion seem excessive.Impaction with that degree of anteversion could compromise a very thin posterior/medial wall product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Mps reported robot issues.Mps reported reaming through medial wall and other issues.As reported via complaint form: after impaction, 48 cup would not stick.Surgeon indicated that posterior wall may have been reamed through.Surgical delay = 15 minutes.Case completed manually.Case type / application: tha 4.0.Update: additional information received from mps: "the surgeon indicated that she did not notice the posterior medial wall having damage until after cup impaction.Another surgeon who helped her with the repair/augment stated that he believed it may have been caused during cup impaction in combination with a thin medial wall as opposed to the reaming portion.".

• Brand Name: TRIDENTII TRITANIUM CLUSTER48D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12824128
• Report Number: 0002249697-2021-01919
• Device Sequence Number: 1377577
• Product Code: LPH
• UDI-Device Identifier: 07613327343861
• UDI-Public: 07613327343861
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 06/30/2026
• Device Model Number: 702-04-48D
• Device Catalogue Number: 702-04-48D
• Device Lot Number: 86431101A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female