MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 8X9CR POLY; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving an unknown insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not returned clinician review: 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: 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.   the following devices were also listed in this report: 8cr press fit femur; cat# unknown; lot# unknown.8 tritanium baseplate; cat# unknown; lot# unknown.A40 cemented patella; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

A (b)(6) yo male's right knee was revised due to infection.The patients primary was previously done at a different facility.The only records that could be found were that it was an 8cr pressfit femur, 8 tritanium baseplate, 8x9cr poly and a a40 cemented patella.The facility was not able to obtain any other information on the initial surgery with respect to parts numbers or lot #'s.The patient's right knee was revised to a ps femur and a ps poly spacer to be staged for a ts at a later date.

• Brand Name: UNKNOWN 8X9CR POLY
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11639747
• MDR Text Key: 245814707
• Report Number: 0002249697-2021-00647
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR