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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Concomitant medical products: catalog number:00875705601 lot number:64531191 brand name: shell with cluster holes.Catalog number:0106010105 lot number:3008526 brand name: avenir stem.Catalog number:00877503202 lot number: 3019131 brand name: biolox head.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.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 the patient dislocated immediately after the initial hip arthroplasty and was revised on the same day.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: LINER NEUTRAL 32 MM I.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10174343
• Report Number: 0001822565-2020-02181
• Device Sequence Number: 3083004
• Product Code: LPH
• UDI-Device Identifier: 00889024149182
• UDI-Public: (01)00889024149182(17)230630(10)64074936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00875101232
• Device Lot Number: 64074936
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100