MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034 2023-02141.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately 4 months post implantation of a right total hip arthroplasty, the patient was experiencing pain and mechanical issues.It was reported that the 28mm inner head had disassociated from the ringloc bipolar cup.Surgical technique was utilized, and the patient's condition and anatomy did not contribute to the event.There were no reported surgical delays or complications.No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6: proposed component code: mechanical (g04) - head.Visual examination of the returned product identified there is scratching and gouging to the liner inside of the shell.The shell has scratching on the od and the lip.The head has scuffing on the od and the flat.The liner was installed in the shell and could not be removed for further evaluation.It is unknown if the damage occurred during explanation or prior.Complaint confirmed based on evaluation of the returned product.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Related to the reported event.Medical records were not provided.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 further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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 further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a6; g3; h2; h6.The following sections were corrected: a1; b5; b7.Medical records/radiographs were provided and review of the available records identified findings of the reported issues er visit.Patient presents with sudden onset right hip pain while walking, patient denies any trauma.At rest, patient is pain free but can no longer bear weight without extreme pain.Hip xray and pelvis ct ordered.X-ray results: destruction of the right medial pectinate line suggestive of pelvic fracture, apparent malrotation involving the acetabular component of the right hip ct results: nondisplaced right pelvic fractures involving the pubic rami as well as the superior acetabulum/acetabular roof.This is associated with malrotated acetabular component of the right hip arthroplasty.Follow up.Patient suddenly developed increased pain, presents for evaluation.Comparison between xrays shows dissociation of the bipolar inner ball from the plastic shell of the prosthesis.Does not report a fall but is having some memory issues.The event is confirmed.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
It was reported that approximately four months post-implantation, the patient was revised due the patient experiencing pain and mechanical issues.It was reported that the head disassociated from the cup.The patient had a sudden pain in the right hip without trauma.X-rays revealed the patient sustained a pelvic fracture with malrotation involving the right acetabular component.During the revision, it was found that the inner head was still attached to the taper and the outer cup was seated in the acetabulum and well-seated to the inner poly portion.The stem was well-fixed and left in-tact while the head and bipolar components were revised without complication.Attempts have been made and no further information has been provided.

• Brand Name: 28MM DIA COCR MOD HD -3MM NK
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17764556
• Report Number: 0001825034-2023-02140
• Device Sequence Number: 6767582
• Product Code: LPH
• UDI-Device Identifier: 00887868308260
• UDI-Public: (01)00887868308260(17)320801(10)J7312706
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K990830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2025

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 Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: J7312706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 08/26/2024; 01/28/2025
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/09/2023; 09/19/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White