MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC®, SL STEM, UNCEMENTED, 5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported that the trial head could not be removed from the stem during the provisional reconstruction.Delay about 10 minutes.No consequences or impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Stem was returned for investigation.The body of the stem is inconspicuous.The neck of the stem shows some scratches.On the taper of the stem, as well as on the contact line between neck and taper, it is possible to see some nicks.These damages were most likely caused in the attempt of removing the trial heads from the stem.Review of the manufacturing records identified no deviations or anomalies during manufacturing.Device used for treatment.Medical records were not provided.With the available information a definitive root cause cannot be established.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.

Event Description

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

• Brand Name: ALLOCLASSIC®, SL STEM, UNCEMENTED, 5, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 16033859
• MDR Text Key: 306431531
• Report Number: 0009613350-2022-00678
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2845
• Device Lot Number: 3089755
• 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: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Prefer Not To Disclose