MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/C; HIP LINER

Model Number	01.32.3239HCT
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 july 2021: lot 1900216: (b)(4) items manufactured and released on 04-apr-2019.Expiration date: 2024-march-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Additional implant involved: 2.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.189641 k112115.Batch review performed on 21 july 2021: lot 189641: (b)(4) items manufactured and released on 21-feb-2019.Expiration date: 2024-feb-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
Event or Problem Description
Revision surgery was performed 1 year and 9 months after the primary surgery due to suspicion of stem mobilization.Pre-revision x-rays suggested stem mobilization.During the surgery, it was confirmed that the stem was well fixed and the surgeon put some bone chips down the stem (the reason is unknown) and replaced the head and liner due to instability.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/C
• Common Device Name: HIP LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12224595
• Report Number: 3005180920-2021-00636
• Device Sequence Number: 4440640
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 03/19/2024
• Device Model Number: 01.32.3239HCT
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 01.32.3239HCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/26/2021
• 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