MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE UNCEMENTED 15 MM POST LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number	00436201500
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02297, 0001822565-2020-02298.Concomitant medical products: part#: 00436004025, lot#: 64464725.Part#: 00434904006, lot#: 64287432.Part#: 0203159040, lot#: 64413211.Part#: 0203159030, lot#: 64523530.Part#: 0203150300, lot#: 4502884436.Part#: 0203150300, lot#: 4502568205.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported patient underwent a shoulder revision approximately four (4) weeks ago due to a broken screw and loose components.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the glenosphere, poly liner, base plate and two locking caps were returned.The two cancellous screws were not returned for evaluation.The base plate exhibits scratches, however, it is unknown if those scratches occurred in the explant process or in-vivo.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: BASE PLATE UNCEMENTED 15 MM POST LENGTH
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10200886
• Report Number: 0001822565-2020-02295
• Device Sequence Number: 11030757
• Product Code: HSD
• UDI-Device Identifier: 00889024489431
• UDI-Public: (01)00889024489431
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00436201500
• Device Lot Number: 64499689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention