MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Catalog Number	00801802801
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: south africa.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision surgery approximately 6 months post implantation due to a dislocation, confirmed by xrays.During the procedure, it was noted that the head came apart from the insert.The components were removed and replaced.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified nicks and gouges around the taper hole from use and explant.Side view of the spherical surface shows wear deformation and scratches.No other damage was noted.Dhr was reviewed and no discrepancies related to the reported event were found.No problem was found with the device, the event was determined to be caused by a previous injury in the patient which caused the fall and subsequently the dislocation.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: FEMORAL HEAD STERILE PRODUCT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15686954
• Report Number: 0001822565-2022-03088
• Device Sequence Number: 15271923
• Product Code: LPH
• UDI-Device Identifier: 00889024144613
• UDI-Public: (01)00889024144613(17)320122(10)65270511
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00801802801
• Device Lot Number: 65270511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT #: P0561E56.AVANTAGE INSERT.LOT #: 0001506720.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 130 KG