MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL 32MM RLC LNR HW SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported patient underwent a closed reduction approximately 1-month implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Pm0003851-kennedy left triflange sz 24-unknown unknown- unknown smith & nephew stem-unknown unknown-unknown smith & nephew head-unknown customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned by patient.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 103532- ti low profile screw 6.5x25mm- 282490.Cp161944- ti lock-scr cancls 6.5x35mm- 263270.103533- ti low profile screw 6.5x30mm- 785590.Cp161944- ti lock-scr cancls 6.5x35mm- 263270.Cp161942- ti lock-scr cancls 6.5x25mm- 455550.Cp161943- ti lock-scr cancls 6.5x30mm- 340960.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.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: ARCOMXL 32MM RLC LNR HW SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14595466
• MDR Text Key: 294155377
• Report Number: 0001825034-2022-01357
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304432458
• UDI-Public: (01)00880304432458(17)220708(10)124800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-105924
• Device Lot Number: 124800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/18/2022; 08/02/2022
• Supplement Dates FDA Received: 07/20/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female