MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Inflammation (1932)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, following a primary tka surgery conducted on (b)(6) 2010 on the patient¿s left knee, the patient began experiencing inflammatory changes that were conservatively treated.As these symptoms did not improve, the patient underwent a revision surgery of the left tka prosthesis on (b)(6) 2018.Amongst the reported findings of this intervention, there was a cyst formation and a partial destruction of the bones in the left knee.The identity of the explanted prosthesis and the prosthesis implanted in exchange remains unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a left total knee arthroplasty revision was performed approximately 8.5 years post implantation due to continued inflammatory changes which were unresolved with conservative treatment.Reportedly, intra-op findings were a cyst formation and a partial destruction of the bones in the left knee.As of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, no definitive clinical factors could be assessed which would have contributed to the event.With the limited information provided, the patient impact beyond the reported inflammatory changes and subsequent revision cannot be determined.No further medical assessment can be rendered at this time.Should clinically relevant documentation become available, the clinical/medical task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include joint tightness, patient condition or postoperative care.The contribution of the device to the reported event could not be corroborated.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15316212
• MDR Text Key: 298873317
• Report Number: 1020279-2022-03874
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Sex: Male