MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0; HIP CERAMIC HEAD

Model Number	01.29.205
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.At 2 weeks after the primary surgery, the surgeon revised all implants and re-implanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 august 2022: lot 2115839: 199 items manufactured and released on 18-feb-2022.Expiration date: 2027-02-09.No anomalies found related to the problem.To date, 174 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved: batch reviews performed on 26 august 2022: amistem-p collared stem size 1 (k173794) lot 2117759: 78 items manufactured and released on 20-apr-2022.Expiration date: 2027-04-04.No anomalies found related to the problem.To date, 38 items of the same lot have been sold without any similar reported event during the period of review.Impact 01.32.148dh acetabular shell ø48 two-holes (k132879) lot 2115080: 104 items manufactured and released on 09-02-2022.Expiration date: 2027-01-30.No anomalies found related to the problem.To date, 68 items of the same lot have been sold without any similar reported event during the period of review.Impact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot 2100152: 165 items manufactured and released on 22-feb-2021.Expiration date: 2026-02-03.No anomalies found related to the problem.To date, 138 items of the same lot have been sold without any similar reported event during the period of review.Impact 01.43.0020 cancellous bone screw ø 6,5 l 20 (k200391) lot 2208669: 317 items manufactured and released on 08-june-2022.Expiration date: 2027-05-17.No anomalies found related to the problem.To date, 125 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0
• Common Device Name: HIP CERAMIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15310353
• Report Number: 3005180920-2022-00651
• Device Sequence Number: 6159370
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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 Model Number: 01.29.205
• Device Catalogue Number: 01.29.205
• Device Lot Number: 2115839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female