MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 36 SIZE M 0; METALLIC BALL HEAD

Catalog Number	01.25.031
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) the medical affairs director performed a clinical evaluation and commented as follows: few days after primary tha the patient dislocated.The only radiographs supplied show the dislocated joint, so position of the femoral component cannot be assessed fully.The therapeutic decision, replacing head and liner only, is suggesting that insufficient muscle tension was detected after primary surgery and this provided insufficient joint stability.A change of the head to a longer one may well solve this problem, but again no postoperative xrays are available to assess this condition.No reason to suspect faulty implants.Batch reviews performed on (b)(6).Lot 162049: 20 items manufactured and released on 24 june 2016.Expiration date: 2021-06-09.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any similar reported event.Impact flat pe hc liner ø36/f, code 01.32.3648hct, lot.167600 (k103721) 77 items manufactured and released on 09 january 2017.Expiration date: 2021-12-14.No anomalies found related to the problem.To date, 47 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain.The patient had dislocated.No trauma reported.The surgeon swapped the head and liner.The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 36 SIZE M 0
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6979311
• Report Number: 3005180920-2017-00611
• Device Sequence Number: 10873665
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 06/09/2021
• Device Catalogue Number: 01.25.031
• Device Lot Number: 162049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/26/2017
• 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: 72 YR