MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	82-7-0708
Medical Device Problem Codes	Crack (1135); Fracture (1260); Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not returned.
Event or Problem Description
Patient was revised on (b)(6) 2018 due to broken insert.Additional information is going to provide from the customer.Update: when the patient stood up from the chair the strange noise was heard.Revision was due to instability of knee.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture of the post of a scorpio tibial ps insert resulting in joint instability was reported.The event was confirmed based on the review of the returned device.Method & results: product evaluation and results: the post fractured from the anterior side to the posterior side due to an overload condition; an indication the insert was loaded from the anterior side.The posterior end of an articulating condyle surface had material loss consistent with the explantation process.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no information was provided for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the event was confirmed based on review of the returned device- the post fractured from the anterior side to the posterior side due to an overload condition; an indication the insert was loaded from the anterior side.The posterior end of an articulating condyle surface had material loss consistent with the explantation process.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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
Patient was revised on (b)(6) 2018 due to broken insert.Additional information is going to provide from the customer.When the patient stood up from the chair the strange noise was heard.Revision was due to instability of knee.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8486429
• Report Number: 0002249697-2019-01543
• Device Sequence Number: 13924204
• Product Code: JWH
• UDI-Device Identifier: 07613327031003
• UDI-Public: 07613327031003
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 82-7-0708
• Device Lot Number: 564YYW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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: 84 YR
• Patient Weight: 50