MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Brand name: femoral head sterile product do not resterilize 12/14 taper.Concomitant medical products: item# xl-200146 act artic hd arcom xl 28x40mm lot# 140070, item# unknown shell lot# unknown, item# unknown stem lot# unknown, item# unknown liner lot# unknown.Product has been received by zimmer biomet and 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 patient underwent revision approximately 3 1/2 months after initial total hip arthroplasty due to disassociation leading to dislocation.Attempts were made to obtain additional information; however none was available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: udi #:(b)(4).Visual evaluation of the returned device shows a versys femoral head locked into a dual mobility bearing.The head moved freely inside of the poly bearing.The conical taper was free of damage and debris.The backside of the poly was severely gouged.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates that the overall fit of the acetabular implant is unremarkable.There is a superlateral dislocation and bone quality is osteopenic.The greater trochanter and entire femoral implant are not entirely included on the image but the portion seen shows abnormal osseous irregularity possibly related to a prior fracture with heterotopic ossification.The acetabular cup abduction angle measures 42 degrees.Anteversion can not be measured on the image.Subsidence or osteolysis can not be excluded.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: SEE H10 NARRATIVE
• 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
• MDR Report Key: 9496009
• Report Number: 0002648920-2019-00903
• Device Sequence Number: 11648151
• Product Code: LPH
• UDI-Device Identifier: 00889024144644
• UDI-Public: 00889024144644
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: N/A
• Device Catalogue Number: 00801802805
• Device Lot Number: 64050706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 05/05/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention