MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 50 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Reaction (2414); Metal Related Pathology (4530)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03659.Concomitant medical devices: catalog number:00620205022 lot number: unknown brand name: acetabular cup; catalog number: 00630505036 lot number: unknown brand name: acetabular liner unknown biolox head.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was on a rowing machine and felt the hip pop leading to a revision surgery approximately 4 and a half years post implantation.During the revision, the surgeon noted liner and locking ring fractured leading the ceramic head and metal cup wear which resulted in metallosis and pseudo-tumor.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.H3 other text: device not returned for evaluation.

Event Description

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

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 50 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10758840
• MDR Text Key: 213857608
• Report Number: 0001822565-2020-03660
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: 00620205022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR