MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE H NEUTRAL LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a manipulation under anesthesia due to subluxation approximately 23 days post right total hip arthroplasty.No devices were removed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 650-0661 ¿ delta ceramic head ¿ 3128008; 010000668 ¿ g7 shell - r7313004a; 51-103150 ¿ taperloc stem ¿ 7198025.Report source: netherlands.Product will not be returned to zimmer biomet for the investigation as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Bending down, felt a pop, pain, no trauma, right leg shortened in flexion, no fractures.Dislocation with reposition under procedural sedation and anesthesia.Symptoms noted as resolved.Sat in chair too deep, luxation of hip (***no documentation that any procedure to reduce hip).Assistance to emergency, re-educated patient on use of high chair and not to flex too deeply.A review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to user error as the patient was not following post-op care and was further educated by the surgeon after the second incident.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: 36MM I.D. SIZE H NEUTRAL LINER
• 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: 16004262
• Report Number: 0001822565-2022-03519
• Device Sequence Number: 20517798
• Product Code: LPH
• UDI-Device Identifier: 00889024519930
• UDI-Public: (01)00889024519930(17)270411(10)65454505
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 30103608
• Device Lot Number: 65454505
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 123 KG