MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT RT 7-8 10M; PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR

Catalog Number	74029272
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.The original operative plan was orif of tibia, but upon entering the capsule surgeon found signs of implant loosening due to septic/aseptic loosening.The surgeon noted oxinium on femur was fine, but surface of poly shows extreme pitting.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirm the stated failure mode.The articular surfaces of the device are heavily pitted from wear.The device was manufactured in 2013.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a traumatic injury.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirm the stated failure mode.The articular surfaces of the device are heavily pitted from wear.The device was manufactured in 2013.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a traumatic injury.

• Brand Name: JRNY II BCS CNSTRD ART ISRT RT 7-8 10M
• Common Device Name: PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10113891
• Report Number: 1020279-2020-01965
• Device Sequence Number: 13915397
• Product Code: JWH
• UDI-Device Identifier: 00885556175262
• UDI-Public: 885556175262
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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: 07/16/2023
• Device Catalogue Number: 74029272
• Device Lot Number: 13GM12674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 07/23/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/10/2020; 08/21/2020
• 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