MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 56MM O.D. SIZE KK POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH KK LINERS; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively, a titanium cup (it cup) of 56 was first used, and then an attempt was made to implant the corresponding polyethylene liner, and it was found that the polyethylene liner and the cup of 56 could not be locked, so the cup was removed and an attempt was made to implant the polyethylene liner outside of the body, and it was found that it could not be locked, and then the surgeon went back to using the larger file, and implanted a cup of 58, and punched the 58 corresponding polyethylene liner, and it was not able to be locked.The doctor had no choice but to remove it, increase the size of the file, and finally used a 60 cup and the corresponding liner to lock it in place.It was reported to cause a sixty (60) minute delay.No other harm to the patient.
Additional Manufacturer Narrative
(b)(4).D10: 00875201232 32mm i.D.Size kk elevated rim liner use with 56mm o.D.Size kk shell 65603763 00875305801 58mm o.D.Size ll porous uncemented with cluster holes shell use with ll liners 65524646 00875201332 32mm i.D.Size ll elevated rim liner use with 58mm o.D.Size ll shell 65714273 g2: china 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.Shell item 00875305601 lot 65540700 shows scratches to the rim face, inner spherical taper wall, and bio debris in fiber metal from attempted use.Visual product identifiers for fiber metal, (3) cluster holes, and (12x) anti rotation scallops were confirmed to print.Dimensional product identifier for overall diameter is in specification.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.Complaint cannot be confirmed.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: 56MM O.D. SIZE KK POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH KK LINERS
• Common Device Name: PROSTHESIS, 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: 19679995
• Report Number: 0001822565-2024-02248
• Device Sequence Number: 15166526
• Product Code: LPH
• UDI-Device Identifier: 00889024150218
• UDI-Public: (01)00889024150218(17)320819(10)65540700
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00875305601
• Device Lot Number: 65540700
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Age: 62 YR
• Patient Sex: Male