MAUDE Adverse Event Report: ZIMMER GMBH ALUMINA CERAMIC HEADS; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source new zealand.The device will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent a revision approximately 19 years post implantation due to poly wear.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d4, d10, g3, h2, h6, h10 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 Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4): this follow-up report is being submitted to relay corrected information, as the investigation summary was erroneously left out of the previous report.The following sections were updated/corrected: b4, h2, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Two images of implant stickers were provided.One of the image shows the implant stickers for the zimmer devices implanted during primary surgery.The second image shows the implant stickers of the devices used for revision surgery.No further medical records were not provided.To what extent the off-label combination of devices potentially caused or contributed to the reported event cannot be determined, especially given the time in-vivo being 19 years.Therefore, based on the given information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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: ALUMINA CERAMIC HEADS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18004396
• MDR Text Key: 326500057
• Report Number: 0009613350-2023-00607
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K030724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2008
• Device Model Number: N/A
• Device Catalogue Number: 172805
• Device Lot Number: 2184182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CLSÂ SPOTORNO, STEM,135Â, UNCEMENTED, TAPER; UNKNOWN LINER; UNKNOWN LINER; UNKNOWN SHELL; UNKNOWN SHELL; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention