MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2101-0200
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/18/2019
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.
Event or Problem Description
Primary procedure, right tha.It was reported that during impaction, the window trial disengage from the impaction handle and was impacted through the acetabulum.The trial was found and removed from the patient.Subsequent trials stayed engaged to the handle as intended.Surgery was completed successfully with a delay of approximately 30 minutes.The rep reported that the device may be available for return, and that he may be able to obtain intra-operative x-rays and the operative report, but does not have access to any additional information.
Event or Problem Description
Primary procedure, right tha.It was reported that during impaction, the window trial disengage from the impaction handle and was impacted through the acetabulum.The trial was found and removed from the patient.Subsequent trials stayed engaged to the handle as intended.Surgery was completed successfully with a delay of approximately 30 minutes.The rep reported that the device may be available for return, and that he may be able to obtain intra-operative x-rays and the operative report, but does not have access to any additional information.
Additional Manufacturer Narrative
Correction: update to catalog number.An event regarding trial/handle disassociation involving a trident trial and cutting edge impactor was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant product 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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Additional Manufacturer Narrative
Reported event: an event regarding trial/handle disassociation and intraoperative fracture involving a trident trial and cutting edge impactor was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as product was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product 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: it was reported that the trident window trial became disassociated from the impaction handle and was impacted through the acetabulum.The trial was found and removed from the patient.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary procedure, right tha.It was reported that during impaction, the window trial disengage from the impaction handle and was impacted through the acetabulum.The trial was found and removed from the patient.Subsequent trials stayed engaged to the handle as intended.Surgery was completed successfully with a delay of approximately 30 minutes.The rep reported that the device may be available for return, and that he may be able to obtain intra-operative x-rays and the operative report, but does not have access to any additional information.Update 13/december/2019 wg: spoke to rep.During impaction, the impactor disengaged from the trial without the surgeon's knowledge.The surgeon believed he was continuing to impact the trial, unaware that the impactor was disengaged.As a result, the impactor slipped through one of the four windows of the trial and punctured the acetabulum.The impactor did not pass straight through the threaded portion of the trial, and was able to be engaged with other trials without disengaging.Surgery was completed as described in the original event description.Rep re-confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8892500
• Report Number: 0002249697-2019-02848
• Device Sequence Number: 286556
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2022

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 Model Number: 2101-0200
• Device Catalogue Number: 2101-0200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 03/07/2022
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 01/17/2020; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male