MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: 25060.2846 BIPOLAR HEAD 28X46; HIP BIPOLAR HEAD

Model Number	25060.2846
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2020: lot 153017: (b)(4) items manufactured and released on 05-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Additional device involved: batch review performed on 27 may 2020: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot 18c0004: (b)(4) items manufactured and released on 17-oct-2018.Expiration date: 2023-09-25.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a disassociation of the bipolar head from the biolox head that was caused when the patient was getting out of bed.The surgeon converted the patient from a bipolar hip to a total hip 3 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta medical affairs director: the bipolar cup had the plastic ring removed; it was not possible to determine the root cause of the event, but it could be probably due to a lever arm that caused the removal of the ring.

• Brand Name: BALL HEADS: 25060.2846 BIPOLAR HEAD 28X46
• Common Device Name: HIP BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10161542
• Report Number: 3005180920-2020-00336
• Device Sequence Number: 2366540
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Expiration Date: 06/30/2020
• Device Model Number: 25060.2846
• Device Catalogue Number: 25060.2846
• Device Lot Number: 153017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR