MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 32MM RLC LNR +5 SZ22; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316); Off-Label Use (1494)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had an initial hip replacement on an unknown date.The patient was then revised for unknown reasons and the liner was replaced.During the procedure, the first liner did not fit into the shell.The surgery was finished with backup liner.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2.D11: 110010243 g7 osseoti 3 hole shell 6561847.010000998 g7 screw 6.5mm x 25mm 6489256.010000998 g7 screw 6.5mm x 25mm 6519889.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.
Event or Problem Description
Not reportable: upon investigation, it has been determined that the device was used in an off label manner.Event is no longer considered reportable, and initial report should be voided.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional/corrected information.Updated: b4, b5, g4, h2, h3, h6 reported event was confirmed by visual examination of returned device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to off label use of items ep-155232 and 110010243.One epoly 32mm rlc lnr +5 sz22 was returned and evaluated.Upon visual inspection there is a circular indentation and a scratch visible on the outside radius on the device.The scallops also have visible damage.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.Not reportable: upon investigation, it has been determined that the device was used in an off label manner.Event is no longer considered reportable, and initial report should be voided.

• Brand Name: EPOLY 32MM RLC LNR +5 SZ22
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9996301
• Report Number: 0001825034-2020-01743
• Device Sequence Number: 11721497
• Product Code: OIY
• UDI-Device Identifier: 00880304451582
• UDI-Public: 00880304451582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2020

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 Expiration Date: 09/21/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-155232
• Device Lot Number: 435460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 06/01/2020; 07/20/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 06/03/2020; 07/21/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; UNKNOWN CUP, UNKNOWN ITEM AND UNKNOWN LOT; UNKNOWN CUP, UNKNOWN ITEM AND UNKNOWN LOT