MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, EXTREMITIES

Catalog Number	11-210063
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: name: explor 18x24 mm implant head, part#: 11-210045, lot#: 294610.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent an initial left elbow procedure.Subsequently under a revision due to pain, weakness, loss of range of motion and loosening approximately four (4) years five(5) months post primary implantation.It was noted that x-rays showed failure of the radial head from the stem with a small fixation screw loose and not attached.No additional information is available at this time.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: radial head removed easily from stem, stem removed with a little more difficulty from the canal.While debriding the radial canal, in the process there was a 4x5mm proximal edge chip off the proximal most radius but there remained a residual three fourths circumference intact sufficient to give good stability.It appears that the screw was left intact to avoid further damage, but unable to determine from dictation.Prosthesis replaced without complication with unknown product.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. .

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9810964
• Report Number: 0001825034-2020-01063
• Device Sequence Number: 653974
• Product Code: KWI
• UDI-Device Identifier: 00880304210462
• UDI-Public: (01)00880304210462
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K040611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 03/05/2024
• Device Catalogue Number: 11-210063
• Device Lot Number: 393080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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
• Patient Weight: 133