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

Catalog Number	01.26.3239HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 october 2018: lot 181533: (b)(4) items manufactured and released on 15-june-2018.Expiration date: 2023-05-23.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 involved in the dislocation and revised: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115).Lot.179841: (b)(4) items manufactured and released on 13-june-2018.Expiration date: 2023-05-28.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.On (b)(4) 2018 the ball head supplier (b)(4) reported the following document review: the component properties and the microstructure as obtained from the quality documents "fullfil" 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.
Event or Problem Description
The patient came in complaining of pain 1 month after primary.The surgeon determined that the patient had dislocated her hip (head dislocated from liner).The patient said that she did not fall or experience any trauma.The surgeon revised the 32m head to a 32l.The liner was not replaced.The surgery was completed successfully.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C
• Common Device Name: HIP HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023980
• Report Number: 3005180920-2018-00854
• Device Sequence Number: 13863117
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 05/23/2023
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 181533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• 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