MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM CEMENTED STD 12/14 NECK SIZE 15 140 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Osteopenia/ Osteoporosis (2651); Joint Impingement (4834)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event was initially reported under the incorrect mfr number on 0001822565-2023-01038.Proposed component code: mechanical (g04)- stem.D10: cat# 30103604, lot# 64797272, g7 vit e neutral lnr 36mm d; cat# 00877503601, lot# 3031184, biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14; cat# unknown, lot# 838baf1806, refobacin bone cement.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.It was reported the patient fell due to unknown reasons and then reported pain, instability, noise, and discomfort.A revision was performed where it was confirmed the stem was confirmed to have subsided and loosened.No immediate complications were noted.The head, stem, and liner were explanted and replaced.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucency surrounding the cemented component of the arthroplasty appears to be consistent with the reported history of aseptic loosening.It was reported the patient fell and began experiencing symptoms.However, as the reason for the fall is unknown, 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
It was reported that the patient underwent an initial right hip arthroplasty.Subsequently, the patient reported a fall occurred on an unknown date and experienced pain and instability.Imaging revealed nonunion of greater trochanter fracture.The patient underwent a revision approximately 2.5 years after initial surgery.The shell was retained, as noted to be well fixed.Surgeon confirmed aseptic loosening at cement mantle, and patient had been experiencing anterior and posterior impingement.Attempts have been made and no further information has been provided.

• Brand Name: FEMORAL STEM CEMENTED STD 12/14 NECK SIZE 15 140 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17163870
• Report Number: 0002648920-2023-00113
• Device Sequence Number: 5818328
• Product Code: JDI
• UDI-Device Identifier: 00889024138261
• UDI-Public: (01)00889024138261(17)300131(10)64608216
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K950312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00785001520
• Device Lot Number: 64608216
• 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: 06/07/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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
• 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: Female
• Patient Weight: 91 KG