MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 13X145; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 110032332- calcar planar shaft-unknown; 110032335- calcar planar head 38mm-unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.
Event or Problem Description
It was reported the echo biometric rpp stem does not line up with same size broach.Did not affect surgery outcome or patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Compatibility was reviewed and it was determined that the instruments used do not align with the instruments recommended by the surgical technique for the reported stem.A definitive root cause cannot be determined; however, off label use may have contributed to the reported event as the instruments used do not align with the instruments recommended by the surgical technique for the reported stem.The identified calcar planar shaft is not compatible with echo biometric rpp stem instruments.The compatible rasp that should be used for implantation of the reported stem is the echo 13x145 rasp.This rasp does not attach to the reported shaft which indicates that an incompatible rasp may have been used.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ECHO POR FEM RED LAT NC 13X145
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10501687
• Report Number: 0001825034-2020-03454
• Device Sequence Number: 14133346
• Product Code: KWA
• UDI-Device Identifier: 00887868273964
• UDI-Public: (01)00887868273964
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192513
• Device Lot Number: 261910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 12/17/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1