MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	626-00-36C
Medical Device Problem Codes	Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Performed a revision surgery on (b)(6) 2021.He removed a cocr mdm liner from a trident ii cup that had been in 15 months.The pt.Complained of pain and effusion.Update 26/february/2021 wg: spoke to rep.Patient also had elevated ion levels.The mdm metal liner, adm/ mdm insert, and ceramic head were revised.Rep reported he may be able to confirm the operative side (as this patient has an identical, as-yet-not-revised construct in his other hip), and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
Dr.Performed a revision surgery on (b)(6) 2021.He removed a cocr mdm liner from a trident ii cup that had been in 15 months.The pt.Complained of pain and effusion.Update 26/february/2021 (b)(6): spoke to rep.Patient also had elevated ion levels.The mdm metal liner, adm/ mdm insert, and ceramic head were revised.Rep reported he may be able to confirm the operative side (as this patient has an identical, as-yet-not-revised construct in his other hip), and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: device: unknown trident ii clusterhole shell; cat#: unknown ; lot#: unknown.Reported event: an event regarding corrosion involving an mdm liner was reported.The event was confirmed based on product inspection.Method & results:  -device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: the liner base material and debris were analyzed using energy dispersive spectroscopy (eds).The eds analysis showed that the liner was consistent with the drawing (astm f1537) and that the debris was consistent with an oxide and corrosion product.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: the liner base material and debris were analyzed using energy dispersive spectroscopy (eds).The eds analysis showed that the liner was consistent with the drawing (astm f1537) and that the debris was consistent with an oxide and corrosion product.-clinician review: no medical records were received for review with a clinical consultant.   -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  -complaint history review: there have been no other similar events for the reported lot.  conclusion: it was reported that the patient was revised due to corrosion.The event was confirmed based on product inspection.Visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: the liner base material and debris were analyzed using energy dispersive spectroscopy (eds).The eds analysis showed that the liner was consistent with the drawing (astm f1537) and that the debris was consistent with an oxide and corrosion product.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11556032
• Report Number: 0002249697-2021-00519
• Device Sequence Number: 3932218
• Product Code: LZO
• UDI-Device Identifier: 04546540665997
• UDI-Public: 04546540665997
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 626-00-36C
• Device Catalogue Number: 626-00-36C
• Device Lot Number: 70669801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention