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

Model Number 626-00-42E

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Anxiety (2328); Injury (2348); Joint Swelling (2356)

Event Date 11/13/2019

Event Type  Injury  

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: delta v-40 ceramic head 28/0; cat# 6570-0-128; lot# unknown.Restoration adm x3 ins 28/48; cat# 1236-2-848; lot# 67333401.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As reported: "left total hip revision.Hip pain." on (b)(6) 2019.Update 06-dec-2019: received a medwatch (mw5091237) stating "after total hip replacement surgery, swelling beyond normal, blistering, the open oozing for 4 months.Joint pains everywhere.Brain fog, blurred vision, fatigue, depression, accelerated heart rate, high blood pressure, anxiety, falling, skin hardening on feet and fingertip, numbness in fingertips and sinusitis.I ask for the components composition and in me is nickel 1.0 max.I have just completed my left revision surgery on [.] 2019.I still have to have the right hip revised." 06-dec-2019: spoke to patient, she stated she still has pain after her left hip revision surgery.Patient also stated she had a right hip replacement done on (b)(6) 2018 and is experiencing pain.Patient said she needs a revision surgery and will schedule it soon.

Manufacturer Narrative

Correction: lot number corrected an event regarding pain involving a mdm liner was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated xrays and examination of explanted components.Product history review: not performed as the reported lot information was invalid.Complaint history review: not performed as the reported lot information was invalid.Conclusion: the event itself cannot be confirmed based on the information provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated xrays and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "left total hip revision.Hip pain." on (b)(6) 2019.Update 06-dec-2019: received a medwatch (b)(4) stating "after total hip replacement surgery, swelling beyond normal, blistering, the open oozing for 4 months.Joint pains everywhere.Brain fog, blurred vision, fatigue, depression, accelerated heart rate, high blood pressure, anxiety, falling, skin hardening on feet and fingertip, numbness in fingertips and sinusitis.I ask for the components composition and in me is nickel 1.0 max.I have just completed my left revision surgery on [.]2019.I still have to have the right hip revised." on (b)(6) 2019: spoke to patient, she stated she still has pain after her left hip revision surgery.Patient also stated she had a right hip replacement done on (b)(6) 2018 and is experiencing pain.Patient said she needs a revision surgery and will schedule it soon.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: 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: 9547810
• MDR Text Key: 188048134
• Report Number: 0002249697-2020-00021
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• Combination Product (y/n): N
• PMA/PMN Number: K103233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 626-00-42E
• Device Catalogue Number: 626-00-42E
• Device Lot Number: 67527102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 78