MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS; PROTHESIS, HIP

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	08/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 00811400300 femoral stem 12/14 neck taper std.Offset size 3 130 mm stem length 65762065, 32833305500 centralizer for use with cpt femoral stems 65086960, 00801102024 allen medullary cement plugs 1-24 mm diameter flange/12 mm diameter core, store in cool dry place 65941524, 00500105200 shell 52 mm o.D.64188733, 802202803 femoral head 12/14 taper 28 mm diameter +3.5 mm neck length 3142865.G2: foreign: singapore product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the bipolar cup liner did not bottom out properly into the patient.The surgeon remarked that the articulation of the bipolar shell and liner construct against the stem trunnion felt unusual and cited the bottoming out issue.A replacement liner was applied using the existing shell and the procedure was completed without any further issues.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, h2, h3, h6 visual examination of the returned product identified liner was returned with lock ring correctly oriented in place.View of the rim from the inner spherical side shows deformation around the diameter.View of the rim from the outer spherical side shows multiple locations of indentation damage to the underside of the rim lip where it seats against the shell.No other damage was noted.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the returned device.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.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17685862
• Report Number: 0002648920-2023-00212
• Device Sequence Number: 6351195
• Product Code: KWY
• UDI-Device Identifier: 00889024633322
• UDI-Public: (01)00889024633322(17)271121(10)65664515
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K833991
• 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): 11/10/2023

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: 00500105028
• Device Lot Number: 65664515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• 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: 08/13/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• 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
• Patient Sex: Unknown