MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ORIGINAL M.E. MULLER, STEM, PT-10, STANDARD, STRAIGHT, CEMENTED, 12.5, TAPER; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 12.00.29-125

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

Patient Problems Ossification (1428); Bacterial Infection (1735); Pain (1994); Osteolysis (2377)

Event Date 06/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: cocr head, xl, 32/+8, taper 12/14; item# 01.01012.328; lot# 2456577.G2 - foreign: germany.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2023-00429.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 surgery approximately two years after initial implantation due to pain and infection.During the revision, the surgeon noted heterotopic ossification, osteolysis of the acetabulum and loosening of the femoral stem.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.The following sections were updated/corrected investigation findings code: malfunction observed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review of the sterilization certificate confirmed no abnormalities or deviations.The reported products were reviewed for compatibility with no issues noted.However, as the liner and shell are unknown, the compatibility of the entire system could not be verified.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.With the available information, a definitive root cause could not be determined for the reported 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 additional information at this time.

• Brand Name: ORIGINAL M.E. MULLER, STEM, PT-10, STANDARD, STRAIGHT, CEMENTED, 12.5, TAPER
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 17432695
• MDR Text Key: 320112480
• Report Number: 0009613350-2023-00428
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592643
• UDI-Public: (01)00889024592643(17)130228(10)2439966
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934159
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 12.00.29-125
• Device Lot Number: 2439966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2008
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 130 KG