MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32 / E

Catalog Number	01.26.3244HCT
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 january 2019.Lot 181144: (b)(4) items manufactured and released on 25 may 2018.Expiration date: 2023-05-08 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.Other devices involved: reference 01.25.025 (k072857) cocr ball head 12/14 ø 32 size xxl +10.5; lot 163216: (b)(4) items manufactured and released on 02 august 2016.Expiration date: 2021-07-18.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.Ceramic ball head not marketed in us.Manufacturer has been informed about the issue.On december 21, 2018 they reported the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Due to a lack of ceramic parts further investigations cannot be done.Clinical evaluation performed by medical affairs director on january 07, 2019.Partial hip revision surgery (stem, head and liner) occurred few months after primary cementless total hip arthroplasty in a (b)(6) year old man.Recurrent dislocations occurred probably during rehabilitation period.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.
Event or Problem Description
The patient was revised two times ((b)(6) 2018) due to hip dislocation, 4 and 5 months after primary.

• Brand Name: LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32 / E
• Common Device Name: LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8235402
• Report Number: 3005180920-2018-01088
• Device Sequence Number: 11161258
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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): 01/10/2019

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: 05/08/2023
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 181144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 90