MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0

Catalog Number 01.29.205

Device Problem Fitting Problem (2183)

Patient Problem Joint Disorder (2373)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05 october 2017.Lot 166415: (b)(4) items manufactured and released on 08 march 2017.Expiration date: 2022-02-26.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 Description

During primary surgery, the surgeon did a trial with size 1 quadra broach and medium head 32mm, and then implanted the same implant sizes.The surgeon told that it was very difficult to reduce it.At the end the leg was about 1,5 cm longer and the patient was not good with that and also couldn't walk well.The surgeon decided to revise it.It was very difficult to get the head off the stem.The surgeon did a new trial and decided to implant a different ball head.The leg length was good post-op.The surgeon stated that, looking at the scratches of the conus in the head, it looks like the head didn't fit correct on the conus.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0
• Type of Device: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6921490
• MDR Text Key: 88921915
• Report Number: 3005180920-2017-00561
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Catalogue Number: 01.29.205
• Device Lot Number: 171408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR