MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH HOLES 58 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Failure to Osseointegrate (1863)

Patient Problems Necrosis (1971); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part: 00771301600, lot: 61454594, modular femoral stem size 16.25; part: 00784802200, lot: 61805988, modular neck b 12/14 neck taper; part: 00801803202, lot: 61829218, femoral head sterile product 12/14 taper; part: 00630505832, lot: 60790062, liner standard 32 mm i.D; part: 00625006525, lot: 61825084, bone scr 6.5x25 self-tap; part: 00625006530, lot: 61850953, bone scr 6.5x30 self-tap.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01741, 0001822565-2021-01742, 0002648920-2021-00168, 0002648920-2021-00362.

Event Description

It was reported the patient underwent a left hip procedure and subsequently, was revised 8 years later due to in-vivo corrosion, elevated metal ions, necrotic tissue and failure to osteointegrate.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6   review of the device history records identified no deviations or anomalies during manufacturing related to the reported event  medical records were provided and reviewed by a health care professional.Review of the available records identified the following: cobalt levels were found to be elevated in february 2019.Within the joint some necrotic tissue was found, and there was a substantial amount of black corrosion in the head and neck junction.The stem was removed without substantial bone loss.The cup was removed with no bony ingrowth found.Rom was found to be satisfactory upon completion.Root cause 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 further event information available at the time of this report.

• Brand Name: SHELL POROUS WITH HOLES 58 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12637404
• MDR Text Key: 276583851
• Report Number: 0002648920-2021-00361
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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 Expiration Date: 12/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 00620005820
• Device Lot Number: 61374944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male