MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR CR KNEE; EMPOWR CR KNEETM TIBIAL INSERT, LEFT, SIZE 7, 10MM

Model Number	344-10-707
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.It is noted that the previous surgery was 3 years ago.Initial or prolonged hospitalization was required.The healthcare professional indicated there was 2 days delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as limited information was provided to djo surgical - austin for review.The revised item was not returned for examination and the item and or lot number was not provided.To adequately investigate this event, the part and or lot number are necessary.In addition to the part and or lot number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.If this information is submitted at a future date, this investigation will be re-evaluated.The root cause of this complaint was a revision surgery due an infection.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.
Event or Problem Description
Revision surgery - patient presented to hospital with significant knee, leg pain and swelling while visiting family in connecticut from california.After initial visit physician diagnosed patient with infection symptoms and contacted djo distributor.

• Brand Name: EMPOWR CR KNEE
• Common Device Name: EMPOWR CR KNEETM TIBIAL INSERT, LEFT, SIZE 7, 10MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9349570
• Report Number: 1644408-2019-01136
• Device Sequence Number: 13966887
• Product Code: JWH
• UDI-Device Identifier: 00190446215134
• UDI-Public: (01)00190446215134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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 Model Number: 344-10-707
• Device Catalogue Number: 344-10-707
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/20/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91