MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CNSTRND HD 12/14 TAPER 36 MM DMTR +3 MM NK LNGTH; PROSTHESIS, HIP

Catalog Number	802403604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a right hip revision approximately three years post implantation due to a dislocation after a fall.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00297.D10: cat #: 010000983 / g7 freedom const e1 lnr 36mm e / lot #: 6728370.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted, to relay additional information.Proposed component code: mechanical (g04), head.Visual examination of the provided pictures identified, the explanted head that is covered in bio-debris.No further evaluation can be made from the provided picture.Medical records were provided and reviewed, by a health care professional in the linked complaint.Review of the available records identified, the following: initial op report reflects revision of unknown head and cup product.No complications noted, hip restrictions emphasized.Medical records, for the revision in this complaint were not provided.The complaint was unable to be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: CNSTRND HD 12/14 TAPER 36 MM DMTR +3 MM NK LNGTH
• 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: 18652319
• Report Number: 0001822565-2024-00383
• Device Sequence Number: 7186740
• Product Code: LPH
• UDI-Device Identifier: 00889024499096
• UDI-Public: (01)00889024499096(17)300831(10)3037243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 05/02/2024

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 Catalogue Number: 802403604
• Device Lot Number: 3037243
• Was Device Available for Evaluation?: No
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 84 KG