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

Catalog Number UNK_SHC

Device Problem Degraded (1153)

Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 12/19/2023

Event Type  Injury  

Event Description

A surgeon presentation was received regarding a patient with a right tha.Cited in the presentation: altr 2 years after tha.(b)(6) 2022: vague, deep groin pain; (b)(6) 2023 progressive pain, loss of rom, groin swelling.Co ¿7.6 ng/ml cr ¿1.7 ng/ml.Msk u/s with a large complex collection around the hip.Path report ¿acute and chronic inflammation with necrosis.Cultures negative.Consistent with altr; revision tha (b)(6) 2023: extensive altr around the hip joint.No muscle damage.Cup and stem not revised.Spoke to rep.Rep was not present for the procedure.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding altr & rom involving an unknown mdm liner was reported.The event was confirmed for altr.Method & results:  -device evaluation and results: not performed as product was not returned.  -clinician review: a review of the provided medical records by a clinical consultant indicated: this case involves a relatively young healthy gentleman who underwent a primary cementless right total hip arthroplasty with an accolade ii stem and an mdm articulation and then developed altr approximately one to two years after implant.A revision was carried out changing the liner and the head.I can confirm that the patient had the primary total hip arthroplasty and the revision arthroplasty since i was able to see x-rays after the primary and after the revision.I do not have the primary operation report or the revision operation report.There is no mention of whether or not there was corrosion.The only mention was of altr surrounding the hip with no muscle damage.The root cause of this event cannot be determined with certainty.Contributing factors to altr include surgical technique factors, especially in the way the modular components are prepared, assembled, and inserted, patient factors such as bmi and activity level, and implant factors.Any explanted prostheses should be submitted to stryker engineers for examination and evaluation. -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that the patient was revised due to altr, rom & pain. a review of the provided medical records by a clinical consultant indicated: this case involves a relatively young healthy gentleman who underwent a primary cementless right total hip arthroplasty with an accolade ii stem and an mdm articulation and then developed altr approximately one to two years after implant.A revision was carried out changing the liner and the head.I can confirm that the patient had the primary total hip arthroplasty and the revision arthroplasty since i was able to see x-rays after the primary and after the revision.I do not have the primary operation report or the revision operation report.There is no mention of whether or not there was corrosion.The only mention was of altr surrounding the hip with no muscle damage.The root cause of this event cannot be determined with certainty.Contributing factors to altr include surgical technique factors, especially in the way the modular components are prepared, assembled, and inserted, patient factors such as bmi and activity level, and implant factors.Any explanted prostheses should be submitted to stryker engineers for examination and evaluation.The exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: UNKNOWN MDM METAL LINER
• Type of Device: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18805812
• MDR Text Key: 336508243
• Report Number: 0002249697-2024-00315
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 79 KG