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

Catalog Number	626-00-42E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for i&d in 2018 due to infection.Patient left a voicemail reporting having a stryker right recalled hip.Patient noted a poly swap in 2008 due to pain.Patient had revision in 2012 due to pain.Patient noted all parts were replaced other then the stem.Patient had a revision in 2016 due to infection where all product was removed.New stryker product implanted in 2017 and patient had a cyst and an i&d in 2018 then a revision in 2019 due to infection.Patient noted she has chron's disease.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name#: restoration adm x3 ins 28/48; cat#1236-2-848.Device name#: delta c-taper head 28mm +0; cat#18-2800.Device name#: ti sleeve for alumina head; cat#17-0000e.Device name#: unknown_joint replacement_product; cat#: unk_jr.Device name#: unknown_joint replacement_product; cat#unk_jr.It cannot be determined which, if any of these devices may have caused or contributed.To the patient's experience.H3 other text: device not returned.
Event or Problem Description
This pi is for i&d in 2018 due to infection.Patient left a voicemail reporting having a stryker right recalled hip.Patient noted a poly swap in 2008 due to pain.Patient had revision in 2012 due to pain.Patient noted all parts were replaced other then the stem.Patient had a revision in 2016 due to infection where all product was removed.New stryker product implanted in 2017 and patient had a cyst and an i&d in 2018 then a revision in 2019 due to infection.Patient noted she has chron's disease.As reported via medwatch reports mw5149918, mw5149919, mw5149920, mw5149921, mw5149922 (all reports have same event description but 1 reported implant each): reporter calling, stating she has had numerous health problems after she was implanted with the "biolox" hip from stryker "some time in 2019." reporter states she learned that her implanted hip system was "recalled" and she has concerns that her health problems are due to this.Reporter states she has memory problems, pain, headaches, nausea, and vomiting, hip dislocating after surgery, and a "cyst or tumor around the hip" currently.Reporter states she additionally had problems walking, has scar tissue, and bone loss.Reporter states she is concerned that the metal in the hip devices is negatively interaction with her body somehow.Reporter additional states she has concerns about 'quality problems" with the mako system that was used during her surgery.Reporter states she is trying to obtain additional records from her doctor's office.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving an mdm liner was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm the surgical procedures during the year 2019 as i was able to review hospital records and operation reports including those for incision and drainage and debridement, as well as revision with poly and head exchange.Root cause analysis: the root causes of this patience difficulties after primary bipolar, hip arthroplasty, including pain, infection, dislocation, and reinfection, cannot be determined with certainty.The causes of these complications are multifactorial including surgical technique which could account for problems such as pain, the fact that the patient had a bipolar implant that had to be revised could be due to pain from the un-resurfaced acetabulum, dislocation can be related to surgical technique, patient factors such as activity level, compliance and bmi, and infection can be caused by contamination at the time of the initial procedure, seeding of the hip from remote sources.In this case the patient has a history of poor dentition.With the information provided with these inquiries i would not assign any causality to the implants themselves." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 3 other similar events for the lot and/or sterile lot referenced.One record relates to infection for the same device/patient; therefore, no further trending is required for this commonality.Two other records also relate to infection.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.Conclusions: it was reported that the patient had a medical procedure due to infection.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm the surgical procedures during the year 2019 as i was able to review hospital records and operation reports including those for incision and drainage and debridement, as well as revision with poly and head exchange.Root cause analysis: the root causes of this patience difficulties after primary bipolar, hip arthroplasty, including pain, infection, dislocation, and reinfection, cannot be determined with certainty.The causes of these complications are multifactorial including surgical technique which could account for problems such as pain, the fact that the patient had a bipolar implant that had to be revised could be due to pain from the un-resurfaced acetabulum, dislocation can be related to surgical technique, patient factors such as activity level, compliance and bmi, and infection can be caused by contamination at the time of the initial procedure, seeding of the hip from remote sources.In this case the patient has a history of poor dentition.With the information provided with these inquiries i would not assign any causality to the implants themselves." furthermore, all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.No further investigation for this event is possible at this time.If devices and/or 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/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18717656
• Report Number: 0002249697-2024-00242
• Device Sequence Number: 20406266
• Product Code: LPH
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 11/30/2021
• Device Catalogue Number: 626-00-42E
• Device Lot Number: 57704803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 50 KG