MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 125, UNCEMENTED, 17, TAPER 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that during a hip arthroplasty, the trial head became jammed on the stem.The head was eventually removed after 10 minutes, and surgery was completed normally.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral head provisional 12/14 neck taper -3.5 mm neck length 32 mm diameter lot#64777899 item#00789503201.Report source: foreign - japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

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 additional information.D-10 biolox delta head 12/14 32x0 item#00-8775-032-02 lot#3103894; continuum tm shell multi 50 hh item#00-8757-050-02 lot#65509208; vit e liner elevated hh 32 item#00-8852-009-32 lot#65254121; trilogy bone scr 6.5x15 item#00-6250-065-15 lot#j7093419; trilogy bone scr 6.5x30 item#00-6250-065-30 lot#j7067957; trilogy bone scr 6.5x40 item#00-6250-065-40 lot#j7149852; trilogy bone scr 6.5x40 item#00-6250-065-40 lot#j7149852.Product remains implanted: no device evaluation could be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: WAGNER CONE PROSTHESIS, 125, UNCEMENTED, 17, TAPER 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15578928
• MDR Text Key: 302773849
• Report Number: 0009613350-2022-00522
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024593190
• UDI-Public: (01)00889024593190(17)270621(10)3117740
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191781
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0100561217
• Device Lot Number: 3117740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose