MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK P1 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Pain (1994); No Information (3190); Metal Related Pathology (4530)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown versys femoral head cat # ni, lot # ni, unknown liner cat # ni, lot # ni, unknown cup cat # ni, lot # ni, unknown stem cat # ni, lot # ni.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00500.

Event Description

It was reported by patient¿s legal counsel that the patient underwent a right total hip arthroplasty.Legal counsel further reports the patient underwent a revision procedure approximately 9 years later for unknown reasons.It was noted the head and taper neck were removed and replaced.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: zimmer item #00620005420 shell porous with holes 54 mm o.D., lot #61008558.Zimmer item #00771300900 modular femoral stem press-fit plasma sprayed cementless size, lot #961332923.Zimmer item #00625006520 bone scr 6.5x20 self-tap, lot #61307746.Zimmer item #00625006525 bone scr 6.5x25 self-tap, lot #61357462.Zimmer item #00625006525 bone scr 6.5x25 self-tap, lot #61357451.The device will not be returned for analysis due to the location of the device is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920¿ 2020-00453, 0002648920- 2020-00454 and 0001822565¿ 2020-00405.

Event Description

It was reported by the patient¿s legal counsel the patient underwent right total hip arthroplasty.Legal counsel further reports patient underwent a revision procedure approximately 9 years later due pain, elevated metal ions, and trunnionosis.It was noted the liner was worn.All implants were removed and replaced with competitor product.No further event information available at the time of this report.

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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision procedure due to failed hip arthroplasty.Blood test results revealed that the patient had elevated metal ions - 6.1 mcg/l cobalt whole blood (high), and 1.3 mcg/l chromium whole blood (slightly elevated).The patient had developed pain.Preop x-rays suggested acetabular asymmetry indicative of poly wear.Trunnionosis was noted during the revision procedure.All zimmer biomet components were replaced with competitor's products.No other findings/complications related to the event were noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.The received additional information does not change the final conclusions of previous investigation.A definitive root cause cannot be determined.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).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted worn / foreign material for the neck.The complaint is confirmed based on the returned devices and medical records.The neck was submitted for further analysis.Analysis determined a consensus modified goldberg score of 4.A score of 4 corresponds to ¿damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris¿.Root cause remains unchanged.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 additional event information to report at this time.

• Brand Name: MODULAR NECK P1 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9681233
• MDR Text Key: 178129125
• Report Number: 0001822565-2020-00405
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182678
• 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: 09/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00784801301
• Device Lot Number: 60796256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 02/17/2021; 09/05/2023
• Supplement Dates FDA Received: 10/12/2020; 02/18/2021; 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2007
• 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
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male