MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC TRIO NO-HOLE Ø 54

Catalog Number	01.26.45.1154
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 25 august 2017 the medical affairs performed a clinical evaluation and commented as follows: total hip revision surgery in an old man ((b)(6) year-old) occurred 2 months after primary surgery.According to the report, the reason for revision is dislocation.The antero-posterior position of the femoral stem looks suboptimal.Batch reviews performed on 04 september 2017.Lot 168187: (b)(4) items manufactured and released on 28 march 2017.Expiration date: 2022-03-15.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.Versafitcup flat pe hc liner ø 32 / e, code 01.26.3244hct, lot.167566 (k103352) lot 167566: (b)(4) items manufactured and released on 25 january 2017.Expiration date: 2022-01-15.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.Cocr ball head 12/14 ø 32 size xl +7, code 01.25.024, lot.164844 (k072857) (b)(4) items manufactured and released on 11 october 2016.Expiration date: 2021-09-28.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.
Event or Problem Description
Revision surgery due to hip luxation.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC TRIO NO-HOLE Ø 54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6851064
• Report Number: 3005180920-2017-00507
• Device Sequence Number: 684400
• Product Code: LZO
• UDI-Device Identifier: 07630030807909
• UDI-Public: 07630030807909
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 03/15/2022
• Device Catalogue Number: 01.26.45.1154
• Device Lot Number: 168187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/08/2017
• 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: 81 YR
• Patient Weight: 70