MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø28/B; ACETABULAR LINER

Catalog Number	01.32.2837HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 november 2019.Lot 176961: 44 items manufactured and released on 01-mar-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold with one similar reported event.Additional implant involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.186530.Batch review performed on 04 november 2019.Lot 186530: 250 items manufactured and released on 29-nov-2018.Expiration date: 2023-11-07.No anomalies found related to the problem.To date, 214 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 8 months after primary surgery, complaining of pain due to dislocation.The stem and head were dislocating from the liner and cup.The cause of the dislocation is unknown.The surgeon revised successfully the head and the liner.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø28/B
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9334342
• Report Number: 3005180920-2019-00974
• Device Sequence Number: 1724514
• Product Code: LPH
• UDI-Device Identifier: 07630030811531
• UDI-Public: 07630030811531
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 02/13/2023
• Device Catalogue Number: 01.32.2837HCT
• Device Lot Number: 176961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/18/2019
• 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: 69 YR