MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/G; HIP HC LINER

Catalog Number	01.32.3252HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2018 lot 134688: (b)(4) items manufactured and released on 13 january 2014.Expiration date: 2021-10-09.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: stem: masterloc 01.39.011 cementless ti coated std stem # 11 (k151531), lot 162767:(b)(4) items manufactured and released on 28 june 2016.Expiration date: 2021-06-15.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: cocr 01.25.025 cocr ball head 12/14 ø 32 size xxl +10.5 (k072857), lot 151915: (b)(4) items manufactured and released on 29 september 2015.Expiration date: 2020-08-31.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: partial revision (stem and head) in primary cementless tha 1,5 years after index operation due to unspecified pain.We only have one intraoperative fluoroscopy shot and the only additional item of information is that the initially suspected infection was not confirmed by analysis.With the information at hand, we cannot draw any conclusion but we see no evidence of a defective device.
Event or Problem Description
The patient came in complaining of pain 1 year and 8 months after primary.The surgeon revised the stem and head with another company's product.The liner was revised with a medacta liner and the surgery was completed successfully.The reason of the pain is unknown.It was thought that the patient may be infected due to swelling.The frozen and micro pathology reports came back negative.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/G
• Common Device Name: HIP HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8188867
• Report Number: 3005180920-2018-01031
• Device Sequence Number: 1900360
• Product Code: LPH
• UDI-Device Identifier: 07630030811999
• UDI-Public: 07630030811999
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 10/09/2021
• Device Catalogue Number: 01.32.3252HCT
• Device Lot Number: 134688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/21/2018
• 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