MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-22-010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
(b)(6).Adverse event description: knee revision to address painful left knee arthroplasty with mid flexion instability and recurvatum deformity.Additional information follow-up request medical records indicated the following with respect to the patient's left, non-study total knee arthroplasty.The operative records indicate that the patient had received a left total knee arthroplasty on (b)(6) 2016, to address osteoarthritis.It was noted that the patient was morbidly obese, with a bmi of 47.There were no reported intraoperative or post-operative complications associated with this primary knee arthroplasty.The following products were implanted: j&j sigma cruciate substituting size 3 left femur component (product #: 196040300), j&j sigma modular tibial tray size 2.5 component (product #: 158125000), j&j sigma all poly 3 peg size 35mm oval dome patella component (product #: 960101), and j&j sigma stabilized tibial insert size 2.5, 10mm thick (product #: 158122010).On (b)(6) 2020, patient's left knee was revised to address painful left knee with mid-flexion instability and recurvatum deformity.At this time, the patient was still morbidly obese, as the patient's bmi was now 52.There was no evidence of infection or implant loosening identified.Scar tissue was excised.It was observed that because of the recurvatum deformity (of 15 degrees in full extension), the post of the stabilized insert was impinging on the box of the femoral component, leading to some damage of the polyethylene insert post.A pfc sigma fixed bearing stabilized tibial insert, size 2.5 x 15mm thick was implanted to achieve correction of the recurvatum deformity and the mid-flexion instability.All other products were retained.Patient's surgery was completed without complications.Doi: (b)(6) 2016, dor: (b)(6) 2020, (left knee).
Event or Problem Description
Adverse event description: knee revision to address painful left knee arthroplasty with mid flexion instability and recurvatum deformity additional information follow-up request medical records indicated the following with respect to the patient's left, non-study total knee arthroplasty.The operative records indicate that the patient had received a left total knee arthroplasty on (b)(6) 2016, to address osteoarthritis.It was noted that the patient was morbidly obese, with a bmi of 47.There were no reported intraoperative or post-operative complications associated with this primary knee arthroplasty.On (b)(6) 2020, patient's left knee was revised to address painful left knee with mid-flexion instability and recurvatum deformity.At this time, the patient was still morbidly obese, as the patient's bmi was now 52.There was no evidence of infection or implant loosening identified.Scar tissue was excised.It was observed that because of the recurvatum deformity (of 15 degrees in full extension), the post of the stabilized insert was impinging on the box of the femoral component, leading to some damage of the polyethylene insert post.A pfc sigma fixed bearing stabilized tibial insert, size 2.5 x 15mm thick was implanted to achieve correction of the recurvatum deformity and the mid-flexion instability.All other products were retained.Patient's surgery was completed without complications.Doi: (b)(6) 2016 dor: (b)(6) 2020 (left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm joint instability.

• Brand Name: SIGMA STAB GVF INS 2.5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10529226
• Report Number: 1818910-2020-19977
• Device Sequence Number: 3056061
• Product Code: JWH
• UDI-Device Identifier: 10603295064091
• UDI-Public: 10603295064091
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1581-22-010
• Device Catalogue Number: 158122010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 10/14/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 09/14/2020; 10/14/2020
• 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: PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PS CEM FEM SZ3 L; SIGMA STAB GVF INS 2.5 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 125