MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R; KNEE CEMENTED FEMUR

Model Number	02.07.0034RP
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 may 2022: lot 2102488: 240 items manufactured and released on 08-apr-2021.Expiration date: 2026-03-23.No anomalies found related to the problem.To date, 230 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting patella instability and the cause is unknown.The surgeon plans to revise the patella in (b)(6) 2022 (primary was on the (b)(6) 2021).No further information is available at this time.More details to follow once revision takes place.
Event or Problem Description
At about 8 months from primary the surgeon revised the patient femur and liner because the femur was implanted in primary without enough external rotation.
Additional Manufacturer Narrative
On the 15th of july we have received the infomation that the revision surgery was peroformed and the event description has been changed as follows: at about 8 months from primary the surgeon revised the patient femur and liner because the femur was implanted in primary without enough external rotation.The femur has been added as product involved.Gmk-sphere 02.12.0722r femoral component sphere tinbn coated size 2+ r lot.2013265 batch review performed on 19 july 2022: lot 2013265: 05 items manufactured and released on 30-mar-2021.Expiration date: 2026-03-21.No anomalies found related to the problem.To date, 4 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14522259
• Report Number: 3005180920-2022-00402
• Device Sequence Number: 6466202
• Product Code: JWH
• UDI-Device Identifier: 07630040711531
• UDI-Public: 07630040711531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2026
• Device Model Number: 02.07.0034RP
• Device Catalogue Number: 02.12.0722R
• Device Lot Number: 2013265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown