MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN INSERT; HIP PROTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Insufficient Information (4580)

Event Date 05/12/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent insert revision due to unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2 ¿ foreign ¿ france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : device location is unknown.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.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 the patient underwent knee revisions surgery due to discomfort feeling of the patient, approximately ten (10) years from initial surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.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.H3 other text : device location is unknown.

Event Description

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

• Brand Name: UNKNOWN INSERT
• Type of Device: HIP PROTHESIS
• 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: 17037204
• MDR Text Key: 316283843
• Report Number: 0009613350-2023-00224
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• 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: 07/18/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN INSERT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 07/13/2023
• Supplement Dates FDA Received: 07/03/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention; Hospitalization