MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C; HIP HC ACETABULAR LINER

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2019: lot 177245: (b)(4) items manufactured and released on 20-feb-2018.Expiration date: 2023-02-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: cup: mpact 01.32.148dh acetabular shell ø48 two-holes(k132879) , lot 178414: (b)(4) items manufactured and released on 03-apr-2018.Expiration date: 2023-03-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115), lot 177694: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Stem: amistem h 01.18.130 ha coated std stem #0 (k093944), lot 131626a: (b)(4) item manufactured and released on 18-feb-2018 (resterilization of the original batch 131626).Expiration date: 2023-01-30.No anomalies found related to the problem.
Event or Problem Description
On (b)(6) 2019 we were informed about a patient who came in due to infection.On the following day a revision surgery was performed 1 year after primary surgery.The pathogen is unknown.The surgeon removed the stem, head, liner and cup and implanted antibiotic spacers.The surgery was completed successfully.

• Brand Name: LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C
• Common Device Name: HIP HC ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8357674
• Report Number: 3005180920-2019-00074
• Device Sequence Number: 2285278
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 02/04/2023
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 177245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/21/2019
• 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