MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +8; HIP CERAMIC HEAD

Model Number	01.29.211
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 146029: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 2019-12-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved in the event: liner: mectacer 01.29.415 ceramic liner ø 36 / g lot.177726 (not registered in usa).Batch review performed on 25 june 2019: lot 177726: (b)(4) items manufactured and released on 12 march 2018.Expiration date: 2023-02-27.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Patient suffered of wound infection which passed into the joint.Staphylococcus was the bacterial infection found after 2 hip washouts that were completed prior to liner and head exchange.In the revision surgery, 2 months after primary, the head and liner were exchanged to provide new bearing surfaces.We became aware of the event on may 27th and the revision surgery was performed on may 29th.
Additional Manufacturer Narrative
The primary surgery date has been corrected it is the (b)(6) 2020.The correct date was discovered during a check with the sales agent on the (b)(6) 2020.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +8
• Common Device Name: HIP CERAMIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8734389
• Report Number: 3005180920-2019-00510
• Device Sequence Number: 19400845
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 12/31/2019
• Device Model Number: 01.29.211
• Device Catalogue Number: 01.29.211
• Device Lot Number: 146029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/21/2020
• 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: 86 YR
• Patient Weight: 120