MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 42MM ID US COCR LNR 54MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71341154

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Injury (2348)

Event Date 10/30/2017

Event Type  Injury  

Event Description

It was reported a revision hip surgery was performed for unspecified reasons.

Event Description

Further information received indicated the patient had persistent pain.Mri suggested a significant soft tissue component and cyst around the greater trochanter.The patient underwent a revision left hip surgery to exchange the liner and the femoral head, debridement of soft tissue component and drainage of cyst.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.During the revision, the r3 liner, hemi head & modular sleeve were removed.The stem & r3 shell remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.It should be noted patient has a history of falls.The iliopsoas abscess was without joint involvement and a physicians note indicated the patient had sepsis with uti that may have seeded into the pelvic and iliacus muscle.As well, the muscle repair.Intraoperative report indicated the anterolateral approach was used, which subsequently led to insufficiency of the abductor mechanism.Therefore it cannot be determined the detachment of the gluteus medius and minimus tendons are related to a failure of the medical device.The pain, brown tissue, cyst, as well as the pathological finding of chronic inflammation are consistent with findings associated with a pseudotumor.However, without the supporting lab results, imaging, or the analysis of the explanted components, the root cause cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 42MM ID US COCR LNR 54MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7007961
• MDR Text Key: 91287797
• Report Number: 1020279-2017-00984
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2019

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: 71341154
• Device Lot Number: 09AW21016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 11/03/2017; 11/03/2017
• Supplement Dates FDA Received: 11/16/2017; 02/13/2018; 10/31/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR