MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEADS; BIPOLAR HEAD Ø28X50

Model Number	25060.2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2024.Lot: 2344786: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-may-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the event, batch review performed on 20 december 2024 ball heads: inox 25055.2803 316lvm ball head 12/14 ø28 mm size m lot: 2410875 (item not registered in us) lot: 2410875: (b)(4) items manufactured and released on 04-oct-2024.Expiration date: 2029-sep-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem c 01.18.151 cemented std stem size1 (k103189) lot: 2204017.Lot: 2204017: (b)(4) items manufactured and released on 27-jun-2022.Expiration date: 2027-jun-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision surgery was performed three days after the primary implantation of a partial hip arthroplasty with a bipolar head.The revision was necessitated by the dissociation of the metallic femoral head from the bipolar head, identified during a ct scan prompted by the patient's complaints of pain.The available ct image clearly confirms this issue.The postoperative x-ray suggests potential doubts regarding the complete coupling of the metallic head into the bipolar head.One possible explanation is that the biological residue may have interfered with the complete reduction.In fact, it is unlikely that this complication developed postoperatively, considering the patient's functional limitations in the immediate postoperative period and the absence of any reported traumatic events.Furthermore, the revision surgery revealed that the stem was loose and required replacement.This additional complication is likely attributable to a potential issue during the cementation phase.However, there is insufficient information to draw a definitive conclusion.
Event or Problem Description
Revision surgery 3 days post primary (patient was still at the hospital) due to dissociation of the inox head from the bipolar head.It was also reported that the amistem-c stem was found loose.All system revised with same references.No traumatic event was reported and no complications occurred during the primary surgery; there were no medacta employees present at either the primary or the revision surgery.
Additional Manufacturer Narrative
Piece returned on (b)(6) 2025.Visual inspection performed by r&d project manager: considering the bipolar head, no particular or evident signs were noticed, except for a deep scratch along the entire width of the polyethylene rim and on the rim of the metal external shell, while some other signs are on the other side of the rim.These signs are probably related to the removal of the implant during the revision.Moreover, the cylindrical entry diameter of the bipolar head and the internal polyethylene ring were measured: the measurements confirmed that the parts were in specification with the drawing.The event may be related to an incomplete insertion of the ball head and/or soft tissue interference that could have reduced the mobility of the bipolar head.From the received information, it is not possible to define a certain root cause.Regarding the stem, some signs of minor damage and scratches are present on both the neck and the body of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.It is not possible to identify the root cause of the reported complaint.Conclusion: there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: BIPOLAR HEADS
• Common Device Name: BIPOLAR HEAD Ø28X50
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21167384
• Report Number: 3005180920-2024-01146
• Device Sequence Number: 9475239
• Product Code: KWY
• UDI-Device Identifier: 07630030843716
• UDI-Public: 07630030843716
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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 Model Number: 25060.2850
• Device Lot Number: 2344786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG