MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II TOTAL KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Calcium Deposits/Calcification (1758); Fall (1848); Failure of Implant (1924); Necrosis (1971); Joint Dislocation (2374); Subluxation (4525); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the coupling pin of a genesis ii pe inlay fractured preoperatively.It is unknown how the procedure was completed or if this caused any delay or harm to the patient.

Event Description

It was reported that after a primary tka was performed on 2008, the patient underwent a revision due to instability of the left knee joint with subluxation (there was an accident in (b)(6) 2021 where the patient fell).The patient was diagnosed with a mechanical defect of a broken insert.During the revision on (b)(6) 2022, it was viewed that the overrun lock of the semi-constrained knee sheared off and lied dorsally behind the femur.This was completely removed and all pieces were removed along with the damaged necrotic tissue around.The tibial and femoral component were also exchanged.The patient is alright and had pain-adapted full load allowed with free mobility.

Manufacturer Narrative

Sections b1, b2 and b5 were updated.Internal complaint reference number: (b)(6) sections d6b, h1 and h6 were corrected.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although the root cause of the reported event could not be definitively concluded, the reported patient fall and length of time in-vivo could not be ruled out as a potential contributing factors along with the increasing left knee complaints ¿for a long time¿.The pathology findings would not be unexpected given the patient¿s medical history with hyperuricemia, fall, broken insert/post with polyethylene abrasion, ¿long time¿ knee complaints with intra-op findings of significant joint destruction and necrotic tissue.The patient impact beyond the reported instability, pseudo-subluxation, clinical/intra-op findings and subsequent revision procedure could not be determined.It was reported that the patient is ¿alright¿ and had ¿pain-adapted full load allowed with free mobility.¿ no further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique and/or patient condition.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: case (b)(4).

• Brand Name: GENESIS II TOTAL KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 14580583
• MDR Text Key: 293278326
• Report Number: 1020279-2022-02735
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

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?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 08/12/2022
• Supplement Dates FDA Received: 07/15/2022; 08/19/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male