MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BIPOLAR INSERT, MODULAR, 42/28; HIP PROSTHESIS

Catalog Number 61.27.28-42

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign- germany d10.Item#:14.28.05-20 ;lot#:3138318 ;item name: cocr head 28/-4 's' 12/14; item#:4712500398-3 ;lot#:axdj2502 ;item name: optipac 40 refob bone cmt r-3 ; item#:01.06010.203 ;lot#: 3119158;item name: avenir, stem, standard, cemented, 3, taper 12/14 ; item#:61.27.00-44 ;lot#:2996323 ;item name: bipolar shell, modular, 44; multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00309.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 implantation of a hip prostheses.Postoperatively during exercise, the head and liner disassociated resulting in hip dislocation.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: b2, b4, b5, d6, g3, g6, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records for the cocr head confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records for the liner cannot be performed without product identification.Devices are used for treatment.The implant protocol for implantation surgery dated 2023 was received.Procedure performed was an implantation of a cemented bipolar prosthesis at the hip.The implanted products are provided.Of note is that the lot number of the liner is not provided.Based on the given information and results of the investigation, a definitive root cause cannot be determined.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.

Event Description

It was reported that patient underwent implantation of a hip prostheses.Postoperatively during exercise, the head and liner disassociated resulting in hip dislocation, which required revision surgery.

• Brand Name: BIPOLAR INSERT, MODULAR, 42/28
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 17161186
• MDR Text Key: 317461218
• Report Number: 0009613350-2023-00292
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024503946
• UDI-Public: (01)00889024503946
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 08/10/2023

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 Catalogue Number: 61.27.28-42
• 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: 05/23/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/11/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female