MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; HIP CEMENTLESS STEM

Catalog Number	01.12.23SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 jun 2019: lot 170195: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 13-june-2022.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 items involved in the event, batch review performed on 17 jun 2019: cup: versafitcup cc trio 01.26.45.1152 acetabular shell cc trio no-hole ø 52 (k122911), lot 171706: (b)(4) items manufactured and released on 08-jun-2017.Expiration date: 28-may-2022.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.Liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e (k103352), lot 173568: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 31-aug-2022.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.Implants from ceramtec 38.49.7175.675.00 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.7011138362 (item not registered in usa).
Event or Problem Description
Revision surgery performed, 1 year and 8 months after primary surgery, due to infection.The pathogen is unknown.All hardware has been removed.
Additional Manufacturer Narrative
On (b)(6) 2019 we received the device visual inspection performed by r&d project manager: femoral stem and acetabular shell show residual bone and signs of removal operation.Femoral head with metal transfer scratch probably due to extraction.It is not possible to determine an implant's related failure root cause.On (b)(6) 2019 we received the name of the pathogen: staphylocoque epidermis.
Event or Problem Description
Revision surgery performed, 1 year and 8 months after primary surgery, due to infection.The pathogen is staphylocoque epidermis.Implant was removed and a spacer was implanted.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764350
• Report Number: 3005180920-2019-00543
• Device Sequence Number: 11182405
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 06/13/2022
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 170195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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: 54 YR
• Patient Weight: 100