MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 44MM O.D. SIZE EE POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH EE LINERS; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the liner did not fix in the cup and while fixing the liner, the acetabular wall of the patient broke.The surgery was delayed two (2) hours.Surgeon had to abandon the case and the patient will need revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) 28mm i.D.Size ee elevated rim liner use with 44mm o.D.Size ee shell (b)(6).(b)(6) bone scr 6.5x25 self-tap (b)(6).(b)(6) bone scr 6.5x25 self-tap (b)(6).(b)(6) bone scr 6.5x30 self-tap (b)(6).G2:foreign:india.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02547.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified shell shows nicks and scratches to the rim face, inner spherical bottom, and scallops.No other damage was noted.Liner shows damage from attempted implant includes a hole through the spherical surface, gouges to the anti rotation scallops and elevated rim, and multiple areas with indentations on the outer spherical surface.The indentation areas align with the shell cluster holes when rotated in multiple positions.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the damage to both returned devices.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

• Brand Name: 44MM O.D. SIZE EE POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH EE LINERS
• Common Device Name: PROTHESIS, HIPS
• 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: 17764738
• Report Number: 0001822565-2023-02546
• Device Sequence Number: 15107750
• Product Code: LPH
• UDI-Device Identifier: 00889024150096
• UDI-Public: (01)00889024150096(17)321113(10)65732263
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00875304401
• Device Lot Number: 65732263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female