MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK P 12/14 NECK TAPER USE WITH +0 HEADS ONLY; HIP PROSTHESIS

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803202, femoral head sterile product do not resterilize 12/14 taper, 61484658, 00771300900, modular femoral stem press-fit plasma sprayed cementless size 9, 61441002.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06246; 0001822565-2017-06245.Reported event was unable to be confirmed as limited information received from the customer.Review of the device history records did not identify any deviations or anomalies related to the reported event.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.

Event Description

It was reported patient received a right revision procedure seven years post-implantation due to elevated metal ion levels.Mri results demonstrated adverse local tissue reaction around the prosthesis and pseudotumors around the hip.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The lot number of 00801803202, femoral head sterile product do not resterilize 12/14 taper, 61484659.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by operative notes received.Right hip revision op notes demonstrated that the patient was revised due to adverse tissue reaction, elevated metal ion levels and pseudotumor.During the revision, significant poly wear was identified.The cup was well-fixed.A new locking ring and liner were implanted.Stem was removed.New competitor¿s stem, neck and head were implanted.Evidence of trunnion wear with metallic wear debris evident.Review of the device history record identified no deviations or anomalies would contribute to reported event.Additional information does not affect the root cause of previous investigation.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.

Event Description

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

• Brand Name: MODULAR NECK P 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7295656
• MDR Text Key: 100893835
• Report Number: 0001822565-2018-01124
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

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: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00784801300
• Device Lot Number: 61346691
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 05/30/2019; 07/19/2019
• Supplement Dates FDA Received: 06/26/2019; 07/24/2019
• 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: 66 YR