MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES; HIP SHELL CEMENTLESS

Catalog Number	01.32.158DH
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 168448: (b)(4) items manufactured and released on 07 march 2017.Expiration date: 02/23/2022.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 component revised: liner: mectacer 01.29.414 ceramic liner ø 36 / f (not marketed in us), lot 157799: (b)(4) items manufactured and released on 04 april 2016.Expiration date: 2021-03-13.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 177707: (b)(4) items manufactured and released on 17 april 2017.Expiration date: 2023-03-27.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
Two months and a half after primary, while the patient was tying the shoe, the hip dislocated (liner/head from cup).The hip was reducted but then dislocated a second time, so the surgeon revised the implant.The surgeon was advised by another orthopedic surgeon who he works with regularly to use a more constrained option for the cup; the second surgeon assisted him during the revision surgery and opted to used zimmer cup (which is what he was used to using).

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: HIP SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8098805
• Report Number: 3005180920-2018-00931
• Device Sequence Number: 2034666
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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): 11/22/2018

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: 02/23/2022
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 168448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/22/2018
• 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: 66 YR