MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: delta v-40 ceramic head 32/-4; cat # 6570-0-032; lot # 80419801.Mod con dist stem 16 x 155 mm; cat # 6276-7-016; lot # caxy814e.23mm mod rev hip bdy/blt +10mmcomponent level 9006-1-123; cat # 6276-1-123; lot # 71313802.Tridentii tritanium multi 48d; cat # 709-04-48d; lot # 74662201a.6.5mm low profile hex screw 20mm; cat # 7030-6520 ; lot # 2nne.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 information by a clinical consultant indicated: it was reported that the patient¿s right hip was revised due to infection.As reported by rep: ¿patient had a periprosthetic fracture, revised to a rest mod.Surgeon stated that the patient subsequently developed mrsa infection due to a house pet.No other information available due to hospital policy.¿rep provided usage sheets and x-rays.A head and liner exchange was performed.Root cause: the root cause of the fracture and the infection cannot be ascertained without additional medical records.Relative to the infection, the most likely cause of a pji in the early postoperative period would be related to the hospitalization not a pet at home.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot and no other similar events were reported for the sterile lot.Conclusions: the event revision due to infection involving a trident liner was reported.The event was not confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.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.  additional information including pathology reports, operative reports, progress notes, 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
It was reported that the patient's right hip was revised due to infection.As reported by rep: "patient had a periprosthetic fracture, revised to a rest mod.Surgeon stated that the patient subsequently developed mrsa infection due to a house pet.No other information available due to hospital policy." rep provided usage sheets and x-rays.A head and liner exchange was performed.

• Brand Name: TRIDENT 10 X3 INSERT 32MM 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: 11991151
• Report Number: 0002249697-2021-01007
• Device Sequence Number: 860823
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 11/30/2025
• Device Model Number: 623-10-32D
• Device Catalogue Number: 623-10-32D
• Device Lot Number: WN89LV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/14/2021
• 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: 66 YR