MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/C

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2018, lot 166654: (b)(4) items manufactured and released on 04 november 2016.Expiration date: 2021-10-24, 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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size l +4 reference 01.29.206 (k112115) lot 161055: (b)(4) items manufactured and released on 18 may 2016.Expiration date: 2021-05-01 no anomalies found related to the problem.To date, (b)(4) tems of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 surgeon notified the sales representative that patient came in complaining of reoccurring hip dislocation.The cause of the dislocation is unknown at this time.The revision date has not been scheduled yet.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 23 march 2018: recurring dislocation in primary cementless tha during the first few months.Cause for dislocation cannot be determined with the information supplied.It is conceivable that the femoral stem may have slightly subsided and the right hip may have lost tension and stability.There is no reason to suspect a faulty device as responsible for the adverse event.Document review received on 26 march 2018 from the supplier of the ball head: the component properties and microstructures as obtained from the quality documents accomplish the requirements.There are no indications of any pre-existing material defect.
Event or Problem Description
Multiple hip dislocation after about 7 months from the primary surgery.Patient has dislocated 3 times: 2 times posteriorly, and 1 time anteriorly primary surgery was perform in posterior lateral approach.The surgeon explanted the cup and liner and implanted another company's product.

• Brand Name: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7338235
• Report Number: 3005180920-2018-00142
• Device Sequence Number: 19348916
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 10/24/2021
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 166654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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: 79 YR
• Patient Weight: 68