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

Catalog Number	00771100900
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: item # 00620005622/ shell porous with cluster holes / lot # 61660755; part # unknown / unknown liner/ lot # unknown; part # unknown / unknown head/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00948, 0001822565 -2021 -00949, 0001822565 -2021 -00950.
Event or Problem Description
It was reported the patient was experiencing the following allegations post revision procedure: significant pain and discomfort; gait, impairment; poor balance; difficulty walking; component part loosening, impingement and/or detachment; metallosis; soft tissue damage; adverse local tissue reaction; dislocation; infection; and other injuries presently undiagnosed, which all require ongoing medical care.However, no further revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected a1; a2; b5; b7; d4; d6; d10; g3; h2; h3; h6 h6-the following codes were reported, however, additional information received from patient's legal counsel.Therefore these codes no longer apply and need removed.Impact codes: 4696 clinical codes: 4350; 2544; 4559; 1930 device codes: 4002 d10 item # 00625006525/ bone screw/ lot #61735449.
Event or Problem Description
It was reported by patient's legal counsel that the patient alleges despite undergoing revision surgery the patient continues to experience pain and discomfort.No revision surgery has been scheduled to date.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; g3; h2; h3; h4; h6.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00229.0002648920-2021-00231.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11607911
• Report Number: 0001822565-2021-00951
• Device Sequence Number: 14275802
• Product Code: MEH
• UDI-Device Identifier: 00889024131743
• UDI-Public: (01)00889024131743(17)210131(10)61690517
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2021

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: 03/31/2018
• Device Catalogue Number: 00771100900
• Device Lot Number: 60921281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 08/24/2021; 09/20/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/06/2021; 08/26/2021; 09/30/2021
• 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: Other
• Patient Weight: 73