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

Model Number	626-00-46F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870)
Date of Event	08/24/2021
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.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.
Event or Problem Description
As reported: "revision of left acetabular component.Surgeon states patient is physically active and presented with pain and fracture of acetabulum.Surgeon states significant adverse local tissue reaction noted during surgery.Surgeon states cup was well fixed." spoke to rep.Rep confirmed patient is very physically active (waterskiing, 72-hole golf, gym, etc).Intra-operatively, the surgeon confirmed that the mdm metal liner was well fixed and well positioned in the shell.Surgeon also confirmed there was no impingement on the femoral stem, and could not provide any possible cause or contributor to altr.A shell with dome hole plug, mdm metal liner, adm/ mdm poly insert, and v40 biolox ceramic head were revised.Rep confirmed there are no allegations against the revised poly insert or ceramic head.Rep provided imaging and primary implant report and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12495369
• Report Number: 0002249697-2021-01572
• Device Sequence Number: 3908170
• Product Code: MEH
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 65543504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/20/2021
• 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
• Patient Age: 54 YR
• Patient Weight: 103