MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-36G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: trident psl ha cluster 58mm; 542-11-58g ; 45317701.25mm mod rev hip bdy/blt +10mmcomponent level 9006-1-125; 6276-1-125 ; 48402101.Dall miles vit 2.0mm cable;6704-8-240;50335001.V40 cocr lfit head 36mm/0;6260-9-136; mnerhe.6.5 cancellous bone screw 25mm; 2030-6525-1;2t1444.6.5 cancellous bone screw 30mm; 2030-6530-1; 3j5hh8.Vit cable crimp sleeve 2.0mm; 6704-4-020; 50499703.Mod con dist stem 17 x 155 mm;6276-7-017; cat10de.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Removal of restoration modular and psl shell and liner due to wound infection.Original surgery from 2015.Replaced with cement spacer.
Event or Problem Description
Removal of restoration modular and psl shell and liner due to wound infection.Original surgery from 2015.Replaced with cement spacer.
Additional Manufacturer Narrative
Correction: update the implant date.Reported event an event regarding infection 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 was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi - 2605566 which is from australia and represents a 71 y/o female patient whose date of implantation is listed as 7/4/15 and explantation 1/20/21.The event description states: "removal of restoration modular and psl shell due to wound infection.Cement spacer from zimmer." undated list of implants: rest.Modular cone body 25/10, 58 trident psl cluster cup, 2 screws, 36/0 v40 lfit head, dall-miles cable set, 17/155 rest.Modular conical stem, 36/0 trident x3 insert.Undated, unlabelled x-ray: ap pelvis: right hybrid tha reduced.Left uncemented revision tha with long stem modular femoral component, 1 cerclage cable, reduced, 2 screws in acetabular shell, tip of stem not visualized, malformation of proximal femur suggesting malunion of fracture.No clinical or pmh, no patient demographics, no operative notes, no examination of explanted components, no laboratory or bacteriology reports, no dated serial x-rays.Based upon the information available for review, neither confirmation of the event description nor preparation of medical report is possible for this case.-product history review: indicated all 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 or sterile lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: based upon the information available for review, neither confirmation of the event description nor preparation of medical report is possible for this case.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.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.

• Brand Name: TRIDENT 10 X3 INSERT 36MM ID
• 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: 11333307
• Report Number: 0002249697-2021-00271
• Device Sequence Number: 19038367
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: 07613327039931
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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 Expiration Date: 12/31/2019
• Device Model Number: 623-10-36G
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 50255501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/30/2021
• 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: 71 YR