MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGEN/RNGLC+ LTD 54MM SZ 23; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ep-108223-e-poly 36mm +3 maxrom lnr sz23-837090, 650-1057-delta ceramic option head dia3 6-811710, 650-1064-cer option type 1 tpr sleve -6 pe 1-938200, 51-106100-tprlc 133 mp type1 pps so 10.0 1-3730440, 103533-ti low profile screw 6.5x30mm ia6.5x30mm-760590, 123741-3/8-24 apical hole plug 1/cup-033860, 103532-bm acet lp dome scw ti s/tap d ia6.5x25mm-893710.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01611.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient was revised approximately 2 years post implantation due to polyethylene wear.During the procedure it was noted that the polyethylene and locking ring were broken.A new polyethylene and locking ring were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported the patient was revised approximately 2 years post implantation due to pain and polyethylene wear.During the revision, it was noted that the locking ring was fractured.The liner and locking ring were replaced without complication.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.Reported event was confirmed by review of medical records and radiographs by a health care professional.X-rays revealed anterior edge wear on the poly and the retaining ring within the shell had fractured.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

• Brand Name: REGEN/RNGLC+ LTD 54MM SZ 23
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9954175
• Report Number: 0001825034-2020-01647
• Device Sequence Number: 2438081
• Product Code: LPH
• UDI-Device Identifier: 00880304451452
• UDI-Public: (01)00880304451452
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K070369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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 Expiration Date: 02/08/2026
• Device Model Number: N/A
• Device Catalogue Number: PT-116054
• Device Lot Number: 690140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/28/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 90