MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; LARGE PROX BODY +0

Catalog Number	308-10-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: 320-10-05 hum-adptpl 5 mm, 320-15-05 glnsphrn-schraube, 320-20-26 kompr-schr,verschl-kap ø 4,5 mm, l 26 mm, 320-20-26, 320-01-38 glnsphre 38 mm, 320-38-00 hum-inlay ø 38 mm, 0°, 320-15-01 glndpl,rev, 320-20-00 drehm-sch,rev, 308-01-09 distaler schaft hrp 9 x 80 mm, 308-05-19 kragen dist.Schaft hrp 19,5 mm, 308-15-01 konus-verrieg.Schr.Hrp 0 mm.
Event or Problem Description
It was reported that a male patient received an hrp prosthesis during revision of a competitor¿s device due to osteonecrosis of the proximal humerus.During an initial revision attempt earlier the same month, an infection was found, and a spacer implanted.The tuberculii were fully necrotized and the rotator cuff not re-fixable.Due to this, a large proximal humeral body in 0°retroversion and a rtsa was implanted.At the time of his last follow-up, the patient was able to elevate his arm up to 120°, without any significant rotation possible.Although satisfied with the function, the joint tends to dislocate anteriorly while sleeping and under stress causing anterior movement of the proximal humorus.The surgeon believes this is due to the 0° retroversion in combination with a too large proximal humerus and is planning to implant a smaller size of the proximal humerus in connection with more retroversion and increase stability with the help of the reverse implants in the future.
Additional Manufacturer Narrative
Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization initial or prolonged.(e3) occupation: physician.(g5) pma/510(k)number: k143659.(h3) the dislocation reported was likely the result of the ¿0° retroversion in combination with a too large proximal humerus¿ and/or the patient¿s anatomy.However, this cannot be confirmed as the devices were not available for evaluation and x-rays were not provided.(h6) evaluation codes: 2374, 2993.Section h11: the following sections have corrected information: (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 05-apr-2019.

• Brand Name: EQUINOXE
• Common Device Name: LARGE PROX BODY +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8758403
• Report Number: 1038671-2019-00360
• Device Sequence Number: 13850817
• Product Code: KWT
• UDI-Device Identifier: 10885862268129
• UDI-Public: 10885862268129
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Catalogue Number: 308-10-05
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: 26 YR