MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE D NEUTRAL LINER; PROSTHESIS, HIP

Catalog Number	30103204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient was evaluated for a subluxation of the right hip approximately twenty months post implantation.The patient was experiencing pain and a clunking sensation while prone.Additional physical therapy was prescribed and the outcome is still pending.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 650-1162 / delta cer fem hd 32/0mm t1 / lot #: 3084053.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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Findings: ae entered for r hip subluxation outpatient physical therapy ordered specifically to work on hip strengthening.Outcome pending.Patient presented to clinic with complaints of possible subluxation.She has felt a sharp pain and clunking sensation x 2 while lying on stomach.Denies any episodes of dislocating.The complaint is confirmed based on the evaluation of the provided medical records.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.

• Brand Name: 32MM I.D. SIZE D 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: 18928464
• Report Number: 0001822565-2024-00907
• Device Sequence Number: 9364660
• Product Code: LPH
• UDI-Device Identifier: 00889024519848
• UDI-Public: (01)00889024519848(17)251029(10)64922381
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 10/29/2025
• Device Catalogue Number: 30103204
• Device Lot Number: 64922381
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White