MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50; DOUBLE MOBILITY ACETABULAR CUP

Model Number	01.32.150MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2021 lot 1901388: (b)(4) items manufactured and released on 17-july-2019.Expiration date: 2024-07-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 14 january 2021 liner: mpact dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot.1901455 lot 1901455: (b)(4) items manufactured and released on 21-may-2019.Expiration date: 2024-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and another similar event has been reported.Stem: amistem-p collared 01.18.433 amistem-p collared std stem size 3 (k173794) lot.1907017 lot 1907017: (b)(4) items manufactured and released on 19-nov-2019.Expiration date: 2024-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.Without any other similar reported event.Ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1908980 sn n/a.Lot 1908980: (b)(4) items manufactured and released on 10-feb-2020.Expiration date: 2025-01-21.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold and another similar event has been reported.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer, 5 months after the primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Initial report and report source have been corrected.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50
• Common Device Name: DOUBLE MOBILITY ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11284520
• Report Number: 3005180920-2021-00084
• Device Sequence Number: 3498750
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 07/06/2024
• Device Model Number: 01.32.150MB
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 1901388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/05/2021
• 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