MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM I.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Numbness (2415); Hyporesponsive to stimuli (2683)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part: 00877703602, lot unk, biolox⮠option, head, m, 㸠36/0, taper 12/14.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised.The patient began reporting numbness, pain, and lack of sensation in their foot.Two different times a closed reduction was performed.Review of the device history records identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
It was reported that the patient underwent a right tha revision and subsequently patient reports right leg pain, numbness, altered sensation and right foot drop.One year post-implantation and 1 1/2 years post-implantation patient seen for right hip dislocations and underwent closed reductions.Remains implanted.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent a right hip revision approximately 2 years post implantation due to right leg pain, numbness, altered sensation, right foot drop and dislocations.The liner was replaced.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Additional medical records were provided and reviewed by a health care professional.Review of the additional records identified the following: the patient underwent a revision of the right hip for the symptoms described, and an unknown constrained liner was placed.Device history record (dhr) was reviewed and no discrepancies 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12627671
• Report Number: 0002648920-2021-00349
• Device Sequence Number: 5823318
• Product Code: LPH
• UDI-Device Identifier: 00889024123922
• UDI-Public: (01)00889024123922(17)230531(10)64052188
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00630506036
• Device Lot Number: 64052188
• 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: 09/17/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 12/28/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/29/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• 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
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 149 KG