MAUDE Adverse Event Report: ZIMMER, INC. REVISION FEMORAL STEM BEADED FULLCOAT PLUS 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Discomfort (2330); Reaction (2414)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant products: unk, unknown versys head, unk.Unk, unknown cup, unk.Unk, unknown liner, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06313.

Event Description

It was reported by the patient's legal counsel that the patient's right hip was revised approximately three years post-implantation due to pain, discomfort, tissue reaction, trunniosis, and elevated metal ion levels.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.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801804003, cocr femoral head, 61790581, 00620205820, shell porous with multi holes 58 mm, 61764051, 00630505840, liner standard 3.5 mm offset 40 mm, 61730068, 00625006520, bone scr 6.5x20 self-tap, 61770032, 00625006520, bone scr 6.5x20 self-tap, 61785591.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action(s) is/are required.Root cause was unable to 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.

• Brand Name: REVISION FEMORAL STEM BEADED FULLCOAT PLUS 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6849129
• MDR Text Key: 85152172
• Report Number: 0001822565-2017-06314
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2018

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784301408
• Device Lot Number: 60954353
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 03/05/2018; 03/29/2018
• Supplement Dates FDA Received: 10/14/2017; 03/28/2018; 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2008
• 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
• Patient Age: 53 YR