MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 32 / C

Model Number	01.26.3239HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2020: lot 182621: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional item involved in the event, batch review performed on 28 april 2020 ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.186540.Lot 186540: (b)(4) items manufactured and released on 06-dec-2018.Expiration date: 2023-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.On (b)(6) 2019, the patient came in reporting pain, which was caused by a leg length discrepancy.The surgeon revised the 32mm biolox s head with a 32mm biolox m head and the surgery was completed successfully.Presently, on (b)(6) 2020, 11 months after primary surgery, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the head and the surgery was completed successfully.
Additional Manufacturer Narrative
In the initial report the report date was wrong.It was corrected with may 19th 2020.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 32 / C
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10069359
• Report Number: 3005180920-2020-00286
• Device Sequence Number: 14391011
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 182621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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: 55 YR