MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS HIP

Catalog Number	00771101040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/18/2020
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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # 00875706201/ shell with cluster/ lot # 64531316; part # 00885101536/ neutral liner/ lot # 63303250; part # 00877503603/ bioloxâ® delta, head/ lot # 3013399.
Event or Problem Description
It was reported that patient underwent a left hip revision surgery 3 months¿ post implantation due to periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following:primary op notes were reviewed and no complications are noted.Medical op notes were reviewed and the following were identified.Follow up: patient reports sweating a lot during sleep, stopped using cane 2 days after surgery, does not need to use walker, no complications on exam.Crf follow up moderate pain/problems, pain 6/10, dissatisfied follow up fever of 101 last night but woke up without a fever, left hip pain increased.X-ray reveals components in satisfactory position, no evidence of loosening, subsidence, wear.Surgeon states i believe his setback is due to him mountain biking the days prior.He seems to have overdone it.A week ago today, he woke up with a fever and had some hip pain.He had one day of fever.He had not had any since that time.Groin pain improving, still having some calf pain, patient has been very active biking and walking aspiration performed, clear bloody fluid returned, sent for cultures and labs to rule out infection.No results provided or further treatment noted in crf; therefore infection likely ruled out and therefore not called out or new complaint required 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12108852
• Report Number: 0001822565-2021-01793
• Device Sequence Number: 4541594
• Product Code: LPH
• UDI-Device Identifier: 00889024131811
• UDI-Public: (01)00889024131811(17)290930(10)64430556
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00771101040
• Device Lot Number: 64430556
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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 Age: 48 YR
• Patient Weight: 90