MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5; METALLIC BALL HEAD

Catalog Number	01.25.015
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: 7.5 years after primary cementless dm tha the patient reported pain, so head and liner were exchanged.The documentation supplied only includes one ap pre-revision xray, which shows, apparently, some degree of leg shortening on the right side (the revised side).We could not establish whether the shortening intervened with time or was an outcome of primary surgery, or indeed if the contralateral side had been lengthened afterwards (less likely).A bone fragment above the acetabular roof is probably not relevant to the problem.The acetabular cup might have tilted and migrated from its original position, but this could not be verified with the information at hand.The cause for the second operation could not be determined with certainty.On (b)(6) 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the parts were analyzed.The cobalt chrome femoral head was inside the pe double mobility liner.The external surface of the liner appeared slightly yellowed but in good conditions, while the inner socket showed some small parts of tissue, most probably blood.Moreover, the inner bottom surface of the ball head appeared to be dirty of blood too.From the analysis of the pieces it is not possible to determine the root cause of the event.Batch review performed on 10 july 2017.Lot 072406: (b)(4) items manufactured and released on 05 december 2007.Expiration date: 2012-10-31.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.Versafitcup double mobility liner ø 60/28, code 01.26.2860m, lot.090903 (k083116) (b)(4) items manufactured and released on 12 june 2009.Expiration date: 2014-04-30.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.
Event or Problem Description
The patient came in complaining of pain.The cause of the pain is unknown.The surgeon revised the head and liner.The surgery was completed successfully.X-rays are available; explants are available.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6705102
• Report Number: 3005180920-2017-00367
• Device Sequence Number: 1038425
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: 10/31/2012
• Device Catalogue Number: 01.25.015
• Device Lot Number: 072406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/12/2017
• 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: 67 YR