MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER ELEVATED RIM 36 MM I.D. SIZE II; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: journal article.Sandip p.Tarpada, md, jeremy loloi, md, evan m.Schwechter, md : a case of titanium pseudotumor and systemic toxicity after total hip arthroplasty polyethylene failure https://doi.Org/10.1016/j.Artd.2020.07.033.It was reported that the patient underwent a head and liner exchange during a surgical hematoma evacuation in an unknown timeframe postop.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a complaint history review and a product hold/recall search will not be performed.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 in a journal article that the patient underwent a revision procedure of the right hip due to the development of a hematoma requiring surgical evacuation.No further event information available at the time of this report.

• Brand Name: LINER ELEVATED RIM 36 MM I.D. SIZE II
• 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: 12376995
• Report Number: 0002648920-2021-00236
• Device Sequence Number: 17277256
• Product Code: LZO
• UDI-Device Identifier: 00889024149724
• UDI-Public: (01)00889024149724(17)201031(10)63200919
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875201036
• Device Lot Number: 63200919
• 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: 08/10/2021
• Initial Report FDA Received Date: 08/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT#: 00877503603 BIOLOX TAPER LOT#: 2839492; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention