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

Catalog Number	00620205020
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	03/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated the product will not be returned to zimmer biomet for investigation as the product remains implanted.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left total hip arthroplasty.Zimmer biomet components were implanted without complications.The patient underwent a revision procedure 2 years later due to loosening of the stem, during when the femoral stem and head were replaced with new zimmer biomet products.The patient underwent a 2nd revision procedure 5 years due to a loose and fractured stem.Upon removing the head, the proximal end of the stem was grossly loose.The cup was well fixed but heterotopic ossification was noted around the acetabulum.An osteotomy was performed to remove the fractured stem, and a competitor's head and stem were implanted.No other complications/findings related to the reported event.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.Concomitant medical products: item# 00801803203/ femoral head / lot # 61945089.Item # 00784301108/ revision femoral stem beaded / lot # 61007312.Item # unknown/ unknown liner / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00520.0001822565 -2020 -00610.
Event or Problem Description
It was reported the patient underwent left hip revision surgery 7 years post implantation due to stem fracture, pan and instability.Cup was retained and head and stem were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a2; a4; a5; b7; g3; h2.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient visited ed with concerns of sepsis, possible infection as well as anemia.Infectious disease consultant agreed no concern for left hip sepsis, also was negative for dvt of lle.No other findings related to the reported event were noted.The additional information received does not change the final conclusions of previous investigation.

• Brand Name: SHELL POROUS WITH MULTI HOLES 50 MM
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11606219
• Report Number: 0001822565-2021-00830
• Device Sequence Number: 3622522
• Product Code: KWZ
• UDI-Device Identifier: 00889024118836
• UDI-Public: (01)00889024118836(17)181031(10)61078342
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 00620205020
• Device Lot Number: 61078342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 07/08/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/07/2021; 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 93