MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ORIGINAL M.E. CDH STEM, CEMENTED, 5.0, 22; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteopenia/ Osteoporosis (2651)

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source- germany.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: the patient underwent a revision procedure due to implant fracture.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Original m.E., low profile cup, cemented, 36/22, item# 632236, lot #a876343.Cemlock bioabsorbable s, item# 010496000, lot# 090102.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was available for evaluation as patient consent could not be obtained.Visual examination of the provided pictures confirmed a broken stem on the distal end.Nothing further can be gained from a review of the photographs.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records and radiographs were provided and reviewed by a health care professional and radiologist.Significant findings from the radiograph review include: overall fit and alignment appears normal.Slightly deformed and flattened right acetabular cup maybe related to known history of multiple prior revisions.No signs of loosening, wear, radiolucency or other contributing factors.Significant findings from the hcp review of the medical records include: fractured single-unit cementitious monobloc stem with 22 head diameter with axial deviation of the femur and marked synovitis and osteolysis after numerous previous surgeries.Acetabulum well fixed and without wear, remained implanted.With the available information, a definitive root cause cannot be determined.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

It was reported initial right total hip arthroplasty on unknown date.Subsequently revised due to fractured implant, synovitis, pain, instability, and osteolysis.During the revision noted significant bleeding throughout the procedure, adhesions, osteotomy for removal of fractured stem.Stem exchanged with surgeon noting the case was extremely difficult related to anatomical conditions, thin bone, fixed distal component portions, fractured component, and significant bleeding tendency.No further event information available at the time of this report.

• Brand Name: ORIGINAL M.E. CDH STEM, CEMENTED, 5.0, 22
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 16183235
• MDR Text Key: 307486238
• Report Number: 0009613350-2023-00013
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923808
• 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,Followup
• Report Date: 07/05/2023

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 Expiration Date: 12/15/2004
• Device Model Number: N/A
• Device Catalogue Number: 30.22.69-050
• Device Lot Number: B674762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 03/10/2023; 06/08/2023
• Supplement Dates FDA Received: 05/23/2023; 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/1999
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 95 KG