MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES; ACETABULAR SHELL CEMENTLESS

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 may 2019 lot 185430: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 2023-11-28.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 implants involved: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721), lot 186972: (b)(4) items manufactured and released on 02-nov-2018.Expiration date: 2023-10-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (complaint 0707-19).Stem: masterloc 01.39.207 cementless ti coated lat stem # 7 (k151531), lot 186730: (b)(4) items manufactured and released on 22-nov-2018.Expiration date: 2023-11-13.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.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115), lot 186550: (b)(4) items manufactured and released on 28-nov-2018.Expiration date: 2023-11-18.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.
Event or Problem Description
About 2 months after primary the surgeon performed a washout and revised the cup, the liner, the head and the stem with another company's products for a hip infection (the pathogen is unknown).The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8607925
• Report Number: 3005180920-2019-00371
• Device Sequence Number: 11347906
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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): 05/14/2019

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: 11/28/2023
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 185430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/14/2019
• 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