MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA; PROSTHESIS, HIP

Catalog Number	00771101600
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Scar Tissue (2060); Tissue Damage (2104)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of medical records, op notes, and radiographs.Dhr was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes dated 6 mar 2019 were reviewed and no complications were noted revision op notes dated 3 july 2019 were reviewed and identified patient was revised due to recurrent dislocations.The patient was kneeling at the edge of the bed trying to reach underneath the bed the get something when he sustained a dislocation.The external rotators were torn from their attachment on the posterior greater trochanter.There were fragments of bone embedded in the external rotators.Impingement of scar tissue noted with well-fixed femoral and acetabular components.Abundant scar tissue, pseudocapsule, and impingement noted with internal rotation.Radiographs were provided and reviewed by a health care professional.Review of the available records identified there is no subluxation or dislocation.There is no osseous coverage of the lateral aspect of the right acetabular component.There is no avulsion fracture at the external rotator insertion.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.0001822565 -2019-03231, 0001822565 -2019 -03232, 0001822565 -2019 -05092.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 patient underwent right hip revision approximately 4 months post implantation due to recurrent dislocations.During the revision procedure, it was noted that the external rotators were torn from their attachment.Abundant scar tissue, pseudocapsule, and impingement were also noted.The head, neck, and liner were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9443935
• Report Number: 0001822565-2019-05093
• Device Sequence Number: 19641314
• Product Code: LZO
• UDI-Device Identifier: 00889024132689
• UDI-Public: (01)00889024132689
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K161830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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 Catalogue Number: 00771101600
• Device Lot Number: 63633114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 93