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

Catalog Number	00875705801
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product will not be released due to hospital policy the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Concomitant medical devices: part #: 00877503201/ bioloxâ head/ lot #: 2698854; part #: 00875201332 / liner/ lot #: 62325592.
Event or Problem Description
It was reported patient underwent revision surgery approximately 8 years post implantation due to psoas pain and possible malposition of the acetabular shell that the surgeon believes to have occurred during initial procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complications noted.Overall fit and alignment appear maintained.The cup abduction angle measures approximately 45 degrees.Anteversion can not be measured.Bone quality is osteopenic.Left hip arthroplasty as noted without acute abnormality.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11496863
• Report Number: 0001822565-2021-00719
• Device Sequence Number: 11504512
• Product Code: LZO
• UDI-Device Identifier: 00889024149809
• UDI-Public: (01)00889024149809(17)180331(10)62325592
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 00875705801
• Device Lot Number: 62355790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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 Weight: 98