MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 32J; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-32J
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding rom involving a trident liner 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 remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "adverse event: there were multiple adverse events the most significant a longstanding infection and multiple failures leading to a dysfunctional tha mega prothesis and chronic drainage and pain.Hazards: no hazards can be specifically linked to stryker components from the data reviewed.This data indicated that the first complaint was related to other company devices and the current device was negative affected by infection.The data surrounding the restoration modular hip construct were not provided.Conclusion of assessment: the indwelling mega prothesis is affected by chronic infection and no evidence of device failure was presented.[.] this case represents, in short, a catastrophic progression of events with multiple revisions, dislocation, and ultimately chronic infection.The initial failures and problems were not linked stryker products." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient continues to experience lack of range of motion and pain after the implantation of stryker hip components.A review of the provided medical files by a clinical consultant was unable to confirm the event.The exact cause of the event could not be determined from the information provided.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.The following devices were also listed in this report: simplex p - us tobra fd 10-pk; cat#61979010; lot#mgy039.Gmrs extension piece 60mm; cat#64956060; lot#cjl9y.Osteolock bone screw 24mm; cat#5260-5-024; lot#58555601.Osteolock bone screw 30mm; cat#5260-5-030; lot#59606201.Osteolock bone screw 40mm; cat#5260-5-040; lot#53520701.Proximal fem comp std; cat#64951001; lot#cjt4h.Mrs fem stem w/o body 17x127mm; cat# 64853117; lot#170520b.Tritanium revision acetabular; cat#509-02-74j; lot#pl4m74.Gmrs extension piece 100mm; cat#64956100; lot#bpa7h.Gmrs extension piece 40mm; cat#64956040; lot#c7c6t.32mm std lfit v40 head; cat#6260-9-132; lot# 50287506.Osteolock bone screw 26mm; cat# 5260-5-026; lot#56420202.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
Event or Problem Description
Patient was first implanted with stryker implants on (b)(6) 2017, he was revised on (b)(6) 2017 due to infection.Patient then underwent surgery on (b)(6) 2018 to address recurrent dislocations and continued infection whereby subtotal synovectomy, heterotopic ossification resection, quadricepsplasty, gluteus tenotomy with repair insertion abx delivery system, xenograft 500mg were carried out.No components were reported to be revised during this procedure.The patient had a positive screen for mrsa from a nasal swab.Patient is still experiencing pain and range of motion issues.Patient's surgeon is recommending amputation.This is for pain/rom after 2018 medical intervention.
Additional Manufacturer Narrative
Reported event: an event regarding rom involving a trident liner 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 remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "adverse event: there were multiple adverse events the most significant a longstanding infection and multiple failures leading to a dysfunctional tha mega prothesis and chronic drainage and pain.Hazards: no hazards can be specifically linked to stryker components from the data reviewed.This data indicated that the first complaint was related to other company devices and the current device was negative affected by infection.The data surrounding the restoration modular hip construct were not provided.Conclusion of assessment: the indwelling mega prothesis is affected by chronic infection and no evidence of device failure was presented.[.] this case represents, in short, a catastrophic progression of events with multiple revisions, dislocation, and ultimately chronic infection.The initial failures and problems were not linked stryker products." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient continues to experience lack of range of motion and pain after the implantation of stryker hip components.A review of the provided medical files by a clinical consultant was unable to confirm the event.The exact cause of the event could not be determined from the information provided.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.
Event or Problem Description
Patient was first implanted with stryker implants on (b)(6) 2017, he was revised on (b)(6)2017 due to infection.Patient then underwent surgery on (b)(6) 2018 to address recurrent dislocations and continued infection whereby subtotal synovectomy, heterotopic ossification resection, quadricepsplasty, gluteus tenotomy with repair insertion abx delivery system, xenograft 500mg were carried out.No components were reported to be revised during this procedure.The patient had a positive screen for mrsa from a nasal swab.Patient is still experiencing pain and range of motion issues.Patient's surgeon is recommending amputation.This is for pain/rom after 2018 medical intervention.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 32J
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14554200
• Report Number: 0002249697-2022-00786
• Device Sequence Number: 17663746
• Product Code: KWZ
• UDI-Device Identifier: 07613327025576
• UDI-Public: 07613327025576
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2022

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: 04/30/2021
• Device Model Number: 690-00-32J
• Device Catalogue Number: 690-00-32J
• Device Lot Number: W780D2
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 100 KG