MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH COCR HEAD 32/+4 'L' 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Subluxation (4525)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).Product not available.

Event Description

It was reported that the patient had a revision due to dislocation.

Event Description

It was reported that the patient had a revision due to dislocation.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: gender: male; age: 76; height: 178 cm; weight: 78 kg; form for documentation of implants (will be reviewed during investigation); photos (will be reviewed during investigation).Zimmer biomet (winterthur) will proceed with the investigation.An additional report will be submitted as soon as the investigation results are available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00683.

Event Description

It was reported that the patient was implanted with a total hip replacement.Subsequently, the patient underwent revision surgery due to dislocation of the head.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient was implanted with a total hip replacement, consisting of a continuum cup, constraint liner, cls stem and a cocr head on (b)(6) 2021.Subsequently, the patient underwent revision surgery on (b)(6) 2021 due to dislocation of the head.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-ray: one radiograph was provided and reviewed by a health care professional.Review of the available image identified a left hip arthroplasty with superior dislocation of the prosthetic femoral head without fracture or evidence of implant loosening.The left hip acetabular cup abduction angle measures approximately 50 degrees.Product evaluation: the cocr head was not returned; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the reported head/liner combination was reviewed for compatibility with no issues noted.However as the stem and shell used are unknown, it is unknown if the entire construct is compatible.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a total hip replacement, consisting of a continuum cup, constraint liner, cls stem and a cocr head on may 25, 2021.Subsequently, the patient underwent revision surgery on sep 06, 2021 due to dislocation of the head.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The cocr head was not returned.However, based on the radiograph obtained, the dislocation can be confirmed.However, a specific cause for the dislocation could not be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: COCR HEAD 32/+4 'L' 12/14
• 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: 13103739
• MDR Text Key: 282901330
• Report Number: 0009613350-2021-00683
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 14.32.07-20
• Device Lot Number: 3029371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 78 KG