MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/G; HIP LINER FLAT PE HC

Catalog Number	01.32.4052HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 122761: (b)(4) items manufactured and released on 26-oct-2012.Expiration date: 2017-09-30.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.One other device was involved in the complaint.Ball heads: mectacer 01.29.233h head biolox option ø 40 (k131518), lot.131062: (b)(4) items manufactured and released on 07-mar-2013.Expiration date: 2018-01-31.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.Clinical evaluation performed by medical affairs director: revision in secondary tha due to excessive leg length, which originated from an attempt to gain stability when recurring dislocation was noted.The cause of this adverse event is not related to a faulty device.
Event or Problem Description
On (b)(4) 2019 we have been informed about a patient who had a primary hip surgery on (b)(6) 2015.Subsequently, the patient came in complaining of instability and the head and liner were revised on (b)(6) 2016 [(b)(4)].Presently, 2 years and 9 months from the last revision, the patient came in complaining of tightness and soreness due to the increased length and associated offset with the longer head from the previous revision.The surgeon plans on removing the current head and liner and trialing a dm converter liner and shorter head.The revision surgery has been scheduled for (b)(6) 2019 due to the patient's request so that the rehab time does not interfere with the patient's work schedule.More details to follow after the surgery has been completed.
Event or Problem Description
On (b)(6) 2019 we have been informed about a patient who had a primary hip surgery on (b)(6) 2015.Subsequently, the patient came in complaining of instability and the head and liner were revised on (b)(6) 2016 [ mdr 2016- 00323].Presently, 2 years and 9 months from the last revision, the patient came in complaining of tightness and soreness due to the increased length and associated offset with the longer head from the previous revision.The surgeon plans on removing the current head and liner and trialing a dm converter liner and shorter head.The revision surgery has been performed on the (b)(6)2019 ball head and liner revised successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/G
• Common Device Name: HIP LINER FLAT PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478397
• Report Number: 3005180920-2019-00243
• Device Sequence Number: 19245134
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 09/30/2017
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 122761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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