MAUDE Adverse Event Report: ZIMMER GMBH MODULAR-BIPOLAR INSERT 28/46; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported patient underwent right hip revision approximately 1 month post implantation due to the inlay and shell were dislocated.

Manufacturer Narrative

(b)(4).G2: report source germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent right hip revision approximately 1 month post implantation due to dislocation.During the revision, the head was found firmly attached to the stem while the bipolar components were found free in the joint.The initial stem was left intact, and all other components were revised.The trochanteric muscles were re-anchored from dislocation damage.The procedure was completed without complications.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MODULAR-BIPOLAR INSERT 28/46
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 19089508
• MDR Text Key: 339982679
• Report Number: 0009613350-2024-00138
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503953
• UDI-Public: (01)00889024503953(17)280925(10)3173338
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 61272846
• Device Lot Number: 3173338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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: AVENIR STD STEM CEMENTED 4.; PROTASUL-S-30-HEAD 28 S.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 95 YR
• Patient Sex: Female
• Patient Weight: 70 KG