MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LZOVERSAFITCUP CC TRIO NO HOLE CUP; ACETABULAR CEMENTLESS SHELL

Catalog Number	01.26.45.1152
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20th dec 2018 the r&d project manager visually checked the "retrived" implant: visual inspection highlights bone residuals on the cup external surface.Signs of extraction, coating loss on the equatorial side.The coating detached from the polar zone during extraction, that remained anchored to the acetabular bone, may highlight that good "osteointegration" was in process.Probably during extraction, the osteotome determined the detachment of the coating from the cup.Batches review performed on 03 january 2019: lot 179143: (b)(4) items manufactured and released on 09 april 2018.Expiration date: 2023-03-26.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.Versafitcup cc pe liner code 01.26.3244hct lot.179308 (k103352): (b)(4) items manufactured and released on 05 april 2018.Expiration date: 2023-03-20.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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size s - code 01.29.204 lot.177688 (k112115): (b)(4) items manufactured and released on 18 april 2018.Expiration date: 2023-04-05.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.Amistem-h proximal coating std stem #5 code 01.18.175 lot.180062 (k161635): (b)(4) items manufactured and released on 08 may 2018.Expiration date: 2023-04-26.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
A few month after the undertaken primary tha, the patient was complaining about remaining pain.After investigation a low-grade infection was diagnosed (staph epidermitis).On (b)(6) 2018, all primary hip components have been revised.During the explantation a chisel was used on the lateral side in order to release the cup; some ha coating remained in the acetabulum which could be removed afterwards.There was no patient harm.

• Brand Name: LZOVERSAFITCUP CC TRIO NO HOLE CUP
• Common Device Name: ACETABULAR CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8211949
• Report Number: 3005180920-2018-01054
• Device Sequence Number: 2112632
• Product Code: LZO
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: 03/26/2023
• Device Catalogue Number: 01.26.45.1152
• Device Lot Number: 179143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/03/2019
• 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