MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 10 DEGREE ELEVATED RIM 32 MM I.D.; PROSTHESIS, 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	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 00620006220, shell porous with holes 62 mm o.D., lot#: 64532838.Catalog#: 00620006420, shell porous with holes 64 mm o.D., lot#: 64621447.Catalog#: 00631006432, liner 10 degree elevated rim 32 mm i.D., lot#: 64206240.Catalog#: 00801803201, femoral head sterile product 12/14 taper, lot#: 64209548.Catalog#: 01.00102.214, wagner sl revision stem 14/225, lot#: 3013788.Catalog#: 103537, ti low profile screw 6.5x50mm, lot#: 900560.Report source: foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00105.
Event or Problem Description
It was reported that after the trilogy acetabular system shell with holes porous was implanted during the operation, the doctor found that the liner could not implant into the shell.After the shell was removed, it was found that the clasp inside the shell could not be moved.The material of the clasp inside the shell was too soft and inelastic.The surgery was completed with an alternate shell and liner.No adverse events have been reported as a result of the malfunction.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.The following sections were updated/corrected updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.The event was confirmed with product received.Upon visual inspection, devices were returned with liner not fully seated in shell.Liner scallops did not line up with shell tabs.Devices were separated for review.The liner shows indentations on the polar boss, outer spherical surface, anti rotation scallops, and lock ring groove.No other damage was noted.The shell shows nicks and gouges to etched face.Lock ring damage was noted in the lock ring groove.Lock ring tabs were correctly oriented in shell tab window.Lock ring was tight and unable to freely move in the shells groove.Lock ring was removed.Lock ring shows deformation, nicks, gouges, and scratches.No other damage was noted.The dimensional analysis of the devices were conforming to specifications during manufacturing.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 32 MM I.D.
• 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: 11770287
• Report Number: 0002648920-2021-00104
• Device Sequence Number: 4244515
• Product Code: LPH
• UDI-Device Identifier: 00889024124905
• UDI-Public: (01)00889024124905(17)230131(10)63891310
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00631006232
• Device Lot Number: 63891310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: SEE H10 NARRATIVE
• Patient Age: 51 YR
• Patient Weight: 50