MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE CR NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-2-0908
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/03/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: scorpio nrg cr femoral component right #11; 80-4411r ; mhan16 series 7000 standard tibia;7115-0009; mhedyy it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Patient participates in the (b)(6).The patient was believed to withdraw study participation on (b)(6) 2011 and was terminated from the study.Actually the patient returned back to clinic for prosthesis removal due to infection (staph.Aureus) and replacement/spacer and replacement on (b)(6) 2012.
Event or Problem Description
Patient participates in the scorpio nrg study k-s-002.The patient was believed to withdraw study participation on (b)(6) 2011 and was terminated from the study.Actually the patient returned back to clinic for prosthesis removal due to infection (staph.Aureus) and replacement/spacer and replacement on (b)(6) 2012.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving scorpio insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: undated x-ray ap and lat right knee - cemented tka no patellar resurfacing, reduced, nominal position.(b)(6) 2011 op note "explantation right tka and spacer implantation" diagnosis infection status post right tka gen anesthesia/ tourniquet.".Coag.Negative staph.Crp elevated.Cement spacer." uncomplicated surgery.(b)(6) 2012 op note "knee prosthesis exchange implantation right.Scorpio nrg ps #11 right femur, #11 tibia, 11/12 insert, 2 units palomed cement.Uncomplicated surgery.No clinical or pmh, no dated serial x-rays, no exam of explanted components, no bacteriology lab reports.Based upon the information available for review, confirmation of the event description or preparation of a medical report is not possible." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for the reported sterile lot.Conclusion: 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.

• Brand Name: NRG KNEE CR NRG BEARING INSERT SIZE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10153614
• Report Number: 0002249697-2020-01185
• Device Sequence Number: 19345529
• Product Code: JWH
• UDI-Device Identifier: 04546540400734
• UDI-Public: 04546540400734
• Combination Product (Y/N): N
• PMA/510(K) Number: K042343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 07/31/2014
• Device Model Number: 82-2-0908
• Device Catalogue Number: 82-2-0908
• Device Lot Number: 30594001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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: 53 YR
• Patient Weight: 105