MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 5 130 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign ¿ united kingdom.The 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 Description

It was reported that there was a revision approximately six years post-implantation due to corrosion of the stem.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d9; d10; g3; h2; h3; h6.Corrected: a3; a4; d4.H6: proposed component code: mechanical (g04): stem.Visual examination of the returned product identified deformation damage mainly to the distal and mid stem section with less on the proximal end.Damage type is unable to be determined and will be sent to the sem lab.Indentations and scratches are present on the stem from use and explant.Ceramic head was returned assembled to the stem.No other damage was noted.The stem was submitted for further analysis.Analysis determined: while some evidence of potential corrosion was observed, the gross material loss appears to be primarily the result of mechanical damage.Please see the report for full details.Semi-quantitative eds elemental analysis found the substrate to remain consistent with cocrmo cobalt alloy.The damaged region was found to have elevated carbon, oxygen, and aluminum.Refer to attached eds report.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.The lab was unable to definitively confirm the corrosion.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 STEM 12/14 NECK TAPER EXT. OFFSET SIZE 5 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18354339
• MDR Text Key: 330869404
• Report Number: 0002648920-2023-00310
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191735
• 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
• Report Date: 05/16/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00811400510
• Device Lot Number: 62315886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2013
• 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: UNK CERAMIC HEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 71 KG