MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MODULAR BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47

Catalog Number	412-02-047
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the head dislocating from the stem and the surgeon replacing the head.
Additional Manufacturer Narrative
The reason for this revision surgery was the head dislocated from the stem.No other information was submitted with this complaint about any patient activities or accidents that may have contributed to the reported event.The previous surgery and the revision detailed in this investigation occurred over 7.8 years apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs), shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the components that may have contributed to reported event.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous surgery.Customer complaint investigation history of the reported device (s) showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the head dislocated from the stem.There were no findings during this investigation that indicate that the reported device (s) was the source or had a direct connection with the reported event.There are multiple factors that may contribute to an event; these are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: MODULAR BIPOLAR HIP
• Common Device Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6301807
• Report Number: 1644408-2017-00049
• Device Sequence Number: 13652621
• Product Code: KWY
• UDI-Device Identifier: 00888912077385
• UDI-Public: (01)00888912077385
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K953510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: 10/28/2013
• Device Catalogue Number: 412-02-047
• Device Lot Number: 53957136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/06/2017
• 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: 86 YR