MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER 28/DMD

Catalog Number	01.26.2848M
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20 october 2017 the (b)(6) performed a clinical evaluation and commented as follows: head and liner revision surgery occurred 8 years after primary double mobility tha.The patient was complaining about pain but femoral stem and acetabular shell were well fixed.The cause for pain cannot be determined with the information at hand.Batch review performed on 30 october 2017.Lot 090083: (b)(4) items manufactured and released on 30 march 2009.Expiration date: 2014-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Additional information received on 31 october 2017 and includes: the cup and stem were well fixed so the surgeon decided to only perform a headliner exchange.From his statement, the osteolysis was in the joint itself.That is why the head and liner were replaced.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined that the stem and cup were well fixed.The surgeon decided to do just a head-liner exchange.Osteolysis was confirmed.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER 28/DMD
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990403
• Report Number: 3005180920-2017-00636
• Device Sequence Number: 13797618
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 02/28/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 090083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• 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