MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD SIZE 2; CEMENTED HIP STEM

Catalog Number	01.18.152
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2019: lot 176514: (b)(4) items manufactured and released on 28-nov-2017.Expiration date: 2022-11-12.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 devices involved.Batch reviews performed on 13 december 2019: ball heads: cocr 01.25.012 cocr ball head 12/14 28 size m 0 (k072857) lot 174666: (b)(4) items manufactured and released on 8-nov-2017.Expiration date: 2022-10-26.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.Cup: versafitcup 01.26.52mb acetabular shell cc 52 (k083116) lot 172681: (b)(4) items manufactured and released on 15-nov-2017.Expiration date: 2022-11-07.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.Liner: versafitcup dm 01.26.2852mhc double mobility hc liner 52/28 (k092265) lot 174323: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-11-06.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(0244-18 mr 2019-00142).Clinical evaluation performed by medacta medical affairs manager: delayed infection in hybrid tha, 2 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed 1 year and 10 months after the primary due to infection and implant mobilization (the pathogen is unknown).The surgeon removed the cup, ball head, liner and stem and insert a spacer.

• Brand Name: STEM: AMISTEM C CEMENTED STD SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494690
• Report Number: 3005180920-2019-01087
• Device Sequence Number: 11504948
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/19/2019

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: 11/12/2022
• Device Catalogue Number: 01.18.152
• Device Lot Number: 176514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/19/2019
• 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: 66 YR
• Patient Weight: 70