MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 28 / B; HIP SHELL LINER

Catalog Number	01.26.2837HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2019: lot 135612: (b)(4) items manufactured and released on 16-january-2014.Expiration date: 2018-11-30.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.Additional devices involved.Batch review performed on 15 july 2019: stem: amistem h 01.18.132 ha coated std stem size 2 (k093944).Lot 153421: (b)(4) items manufactured and released on 21-october-2015.Expiration date: 2020-10-11.No anomalies found related to the problem.To date, 90 items of the same lot have been already sold without any similar reported event.Ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857).Lot 141730: (b)(4) items manufactured and released on 29-july-2014.Expiration date: 2019-06-31.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.
Event or Problem Description
The patient was complaining of a leg length discrepancy so stem, head and liner have been revised 1 year and 8 months after primary, the cup has been left in situ.The surgery was completed successfully.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 28 / B
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8826040
• Report Number: 3005180920-2019-00573
• Device Sequence Number: 11347140
• Product Code: LZO
• UDI-Device Identifier: 07630030807053
• UDI-Public: 07630030807053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122911
• 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
• Report Date (Section B): 07/25/2019

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: 11/30/2018
• Device Catalogue Number: 01.26.2837HCT
• Device Lot Number: 135612
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/25/2019
• 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: 66 YR
• Patient Weight: 57