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

Model Number	626-00-48G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hematoma (1884)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name: tridentii tritanium multi 60g; cat#:709-04-60g; lot#: 72960101a.Device name: 6.5mm low profile hex screw 30mm; cat#: 7030-6530; lot#: 35ph.Device name: 6.5mm low profile hex screw 20mm; cat#: 7030-6520; lot#: 3m6a.Device name: restoration adm x3 ins 28/54; cat#: 1236-2-854; lot#: 73115601.Device name: 6.5mm low profile hex screw 20mm; cat#: 7030-6520; lot#: 6gla.Device name: 6.5mm low profile hex screw 35mm; cat#: 7030-6535; lot#: 3j2a.Device name: c-taper cocr lfit head 28mm/+5; cat#: 06-2805 ; lot#: p24py0.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Based on medical review: "on exam a large subcutaneous hematoma/ seroma was noted, and it was aspirated for 200 cc of bloody fluid.
Event or Problem Description
Based on medical review: "on exam a large subcutaneous hematoma/ seroma was noted, and it was aspirated for 200 cc of bloody fluid.
Additional Manufacturer Narrative
Reported event an event regarding patient factors involving a mdm liner was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted -medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: instability of the hip was confirmed as was the revision surgery.The cause for the instability may be better assessed with review of sequential x-rays to evaluate the position of the acetabular component and changes thereof.Obtaining the implant may provide insight into the mechanism of failure of the polyethylene and failure of the cup to in-grow.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that a large subcutaneous hematoma/ seroma was noted, and it was aspirated for 200 cc of bloody fluid.The exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If additional information become 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: 10611776
• Report Number: 0002249697-2020-02024
• Device Sequence Number: 13562325
• Product Code: LZO
• UDI-Device Identifier: 04546540666031
• UDI-Public: 04546540666031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: No Information
• Device Model Number: 626-00-48G
• Device Catalogue Number: 626-00-48G
• Device Lot Number: 72885801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/27/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 71