MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SLEEVE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-50E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Anxiety (2328); Injury (2348); Joint Swelling (2356)
Date of Event	11/13/2019
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.Device not returned.
Event or Problem 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." 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.
Event or Problem 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." 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.
Additional Manufacturer Narrative
An event regarding pain involving an unknown sleeve 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.

• Brand Name: UNKNOWN SLEEVE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9547793
• Report Number: 0002249697-2020-00022
• Device Sequence Number: 11348332
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 542-11-50E
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/14/2020
• 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: 50 YR
• Patient Weight: 78