MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC Ø 56; ACETABULAR CUP

Catalog Number	01.26.56MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2019: lot 180129: (b)(4) items manufactured and released on 09-may-2018.Expiration date: 2023-04-25.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.162715.Batch review performed on 18 july 2019: lot 162715: (b)(4) items manufactured and released on 29-jul-2016.Expiration date: 2021-07-20.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.Additional implant involved: liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø 56/28 (k092265) lot.183113.Batch review performed on 18 july 2019: lot 183113: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Additional implant involved: stem: quadra-h 01.12.036 cementless, ha coated lat stem # 6 (k082792) lot.070490a.Batch review performed on 18 july 2019: lot 070490a: (b)(4) item manufactured and released on 09-oct-2018.Expiration date: 2023-09-26.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.
Event or Problem Description
Patient presented with infected hip 6 weeks post op.Surgeon has explanted prosthesis to treat infection with antibiotic spacer.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC Ø 56
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8883098
• Report Number: 3005180920-2019-00679
• Device Sequence Number: 16778668
• Product Code: MEH
• UDI-Device Identifier: 07630030808173
• UDI-Public: 07630030808173
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083116
• 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): 08/12/2019

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: 04/25/2023
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 180129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/12/2019
• 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: 59 YR
• Patient Weight: 106