MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH 60MM O.D. SIZE MM POROUS UNCE WITH CLUSTER HOLES SHELL USE WITH MM LINERS; CONTINUUM AND TRILOGY INTEGRATED TAPER ACETABULAR SYSTEMS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer did receive pictures for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00142; 0009613350-2022-00143; 0009613350-2022-00144.

Event Description

It was reported that the patient slipped, resisted the fall.After 2 days, crepitation appeared in the area of the left hip joint.After the x - ray images were taken, a decision was made on the revision operation.

Event Description

Investigation of this incident is currently ongoing.Further analysis of the event has determined that according to complaint description: noise in the joint, the main reportable devices are the articulating components head and liner which have been reported in two separate medwatch.The device previously submitted on this medwatch is a concomitant and not a main device of this event.Please remove 0009613350-2022-00145 from your records.

Manufacturer Narrative

Investigation of this incident is currently ongoing.Further analysis of the event has determined that according to complaint description: noise in the joint, the main reportable devices are the articulating components head and liner which are reported in: 0009613350-2022-00142 head.0009613350-2022-00143 liner.The device previously submitted on this medwatch is a concomitant and not a main device of this event.Please remove 0009613350-2022-00145 from your records.Once the investigation is completed, supplemental medwatch reports for the above mentioned references for the head and liner will be submitted.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.Zimmer reference: (b)(4).

• Brand Name: 60MM O.D. SIZE MM POROUS UNCE WITH CLUSTER HOLES SHELL USE WITH MM LINERS
• Type of Device: CONTINUUM AND TRILOGY INTEGRATED TAPER ACETABULAR SYSTEMS
• 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: 13731051
• MDR Text Key: 286988693
• Report Number: 0009613350-2022-00145
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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 Model Number: N/A
• Device Catalogue Number: 00-8757-060-01
• 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: 02/10/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 04/07/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention