MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Catalog Number	71932635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the patient had implantation on (b)(6) 2020.Since september, the patella of the patient has gone thinner gradually.Therefore, on (b)(6) a bone fracture (patella) was found.The patient did not have traumatic events and rheumatoid arthritis.Revision surgery is not scheduled.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after three requests, smith and nephew has not received supportive clinical documentation to fully evaluate the complaint nor determine a root cause of the reported failure.Although it was reported the patient experienced a patella fracture, a revision surgery has not been scheduled.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided this complaint will be re-assessed.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include but are not limited to abnormal loading of limb or excessive forces applied to implant.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GEN II 7.5MM RESUR PAT 29MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10912996
• Report Number: 1020279-2020-06839
• Device Sequence Number: 3043453
• Product Code: JWH
• UDI-Device Identifier: 00885556056516
• UDI-Public: 885556056516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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: Lay User/Patient
• Device Catalogue Number: 71932635
• Device Lot Number: 19HM12192
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 09/07/2021
• Initial Report FDA Received Date: 11/27/2020
• Supplement Report FDA Received Date: 11/27/2020; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEYTIBIABASENPRTSZ4/74022214/18KM00440; JRNYIIBCSFEMORALOXINRTSZ3/74022113/20BM02771; JRNYIIBCSXLPEARTISRTSZ3-4-RT11MM/74027233/18CM2138; JOURNEYTIBIABASENPRTSZ4/74022214/18KM00440; JRNYIIBCSFEMORALOXINRTSZ3/74022113/20BM02771; JRNYIIBCSXLPEARTISRTSZ3-4-RT11MM/74027233/18CM2138
• Outcome Attributed to Adverse Event: Other