MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 20 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Subluxation (4525); Metal Related Pathology (4530)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left total hip arthroplasty.Subsequently, the patient was revised approximately 1 year later due to pain and hematoma from an unknown injury to left leg.During the revision noted metallosis, scarring and local tissue reaction.The head, neck, and liner were exchanged, the cerclage wires were removed and i&d to hematoma without complications.Subsequently an irrigation and debridement was performed approximately seven (7) months after revision due to recurrent hematoma with 3 previous aspirations with negative cultures.The large hematoma was excised with drain placed without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2023 - 00155.D10: cat# 00-2232-004-18, lot# 63674177, cable ready gtr cocr cable.Cat#00-2232-004-18 ,lot# 63716290, cable ready gtr cocr cable.Cat# 00-6202-058-22 ,lot# 63365727, tm acet shell 58mm cluster.Cat# 00-7713-013-00, lot# 63675172, m/l tpr kinectiv stem sz 13.5.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: additionally, it was reported the patient was experiencing multiple subluxation events prior to the revision.A definitive root cause cannot be determined for all issues reported besides the hematoma.No problem was found with the devices regarding the hematoma, as review by a hcp determined it was procedure related.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: LINER 20 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17325980
• Report Number: 0001822565-2023-01886
• Device Sequence Number: 12140000
• Product Code: LPH
• UDI-Device Identifier: 00889024125636
• UDI-Public: (01)00889024125636(17)220331(10)63624802
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00632005832
• Device Lot Number: 63624802
• 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: 07/07/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male