MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH #3 UNKNOWN SCREW; HIP PROSTHESIS

Model Number N/A

Device Problems Osseointegration Problem (3003); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - unknown ms-30 stem, item# unknown, lot# unknown; unknown sl shell; item# unknown; lot# unknown; #1 unknown screw; item# unknown; lot# unknown; #2 unknown screw; item# unknown; lot# unknown; unknown metasul 28mm head; item# unknown; lot# unknown; unknown metasul 28mm bearing; item# unknown; lot# unknown; unknown cement; item# unknown; lot# unknown.G2 ¿ foreign ¿ switzerland multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00315, 0009613350-2023-00316, 0009613350-2023-00317, 0009613350-2023-00318, 0009613350-2023-00320, 0009613350-2023-00321.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent left hip revision surgery due to significant femoral and acetabular osteolysis about seventeen and half (17,5) years after an initial surgery.During the revision, adverse local tissue reaction with black discolored debris was noted.The stem was found to be loose and subsided and was easily removed.Bone defects with osteolytic changes were encountered in the femur and acetabulum.The atrophied gluteal and abductor tissues were repaired.All implants were exchanged without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Patient developed progressive pain on exertion, significant abductor and iliopsoas insufficiency noted.Extensive osteolysis noted radiographically in the proximal third of the femur and around the acetabulum.In the socket area, a significantly sunken cemented ms-30 prosthesis can be seen with medially proximally largely absent cortex with osteolytic loosening.¿ (stem).In the acetabulum is a ¿sl pan fixed with three titanium screws with a 28 metasul inlay".Abductors show significant weakness (atrophy), ¿black discolored debris¿ noted.Pseudocapsule dissected and sent to pathology to rule out alval, no suspicion of infection.Stem definitively loose, removed easily.Extensive bone defects and osteolytic changes noted in the acetabulum upon removal of the shell, debris tissue cleared from the area.Final implants placed, checked radiographically intraop, good rom and equal leg length.Abductor and surrounding tissues repaired.Postop precautions provided, no intraop complications noted.With the available information, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: #3 UNKNOWN SCREW
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17169447
• MDR Text Key: 317640319
• Report Number: 0009613350-2023-00319
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/13/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male