MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: unknown stem.Multiple reports were submitted along with this report 0001822565-2021-01045.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 was revised due to elevated metal ion levels and pseudotumor approximately 7 years post implantation.Additional information on the reported event is unavailable.
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.Intraoperative photographs and photographs of the explanted products were provided.Visual evaluation identified the following: there is discoloration on the trunnion and in the head's taper.The explanted products were covered in biodebris.No further evaluation is possible using the images provided.A 12/14 cocr femoral head and the associated liner were returned.There were no allegations against the liner.Therefore, no dimensional or visual analysis was performed on the liner.Visual evaluation of the head identified the following: there were gouges around the other surface.Dark foreign debris was present in the taper.No other damage was noted.Further analysis of the head revealed the following: the taper of the returned device was reviewed via optical microscopy (magnification range 5x - 50x) using a keyence vhx-1000 digital microscope and the taper was assigned a modified goldberg score of 4.A score of 4 corresponds to damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris.Complaint sample was evaluated and the reported event was confirmed.Review of the head's device history records identified no deviations or anomalies during manufacturing.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: FEMORAL HEAD STERILE PRODUCT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11671558
• Report Number: 0002648920-2021-00082
• Device Sequence Number: 3156728
• Product Code: LPH
• UDI-Device Identifier: 00889024144736
• UDI-Public: (01)00889024144736(17)300424(10)62676337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 62676337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82