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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: constrained liner 10 degree oblique face; catalog no#: 6154-56-32; lot#: 60547153.Concomitant therapy date: (b)(6) 2020.The manufacturer did receive x-rays, medical reports for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).

Event Description

Patient was implanted on the left side and underwent revision surgery due to unknown reasons.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: according to the received medical records the head and the constrained liner were implanted on (b)(6) 2007 and revised on (b)(6) 2020 due to a disengagement of the ring on the constrained liner.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-rays: an x-ray review has been performed on two undated x-rays.No anomalies relevant to the reported event in regards to the head were identified.Surgical report: the surgical report of the implantation surgery, dated (b)(6) 2007 has been reviewed.No conspicuous findings relevant to the reported event have been identified.Patient data: female, born in 1948.Product evaluation: visual examination: the head and the liner were received for investigation.The articulation surface of the head shows some scratches and some matt metallic smearing.The head taper shows no considerable deteriorations.The metallic ring and the polyethylene part of the liner are disassembled.Nothing conspicuous can be observed about the metallic ring.One of the flaps on the liner's rim is bended inwards while one of the flaps shows considerable wear.The lateral rim of the liner shows signs of delamination.On the backside of the liner, the spherical part, rotational scratches around the pole can be observed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records of the head identified no deviations or anomalies during manufacturing.Conclusion: according to the received medical records the head and the constrained liner were implanted on (b)(6) 2007 and revised on (b)(6) 2020 due to a disengagement of the ring on the constrained liner.Nothing conspicuous about the head could neither be observed on the x-ray nor during the visual examination.The metallic smearing most likely occurred during removal.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).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer 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: COCR HEAD 32/+4 'L' 12/14
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9883979
• MDR Text Key: 193904959
• Report Number: 0009613350-2020-00149
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 14.32.07-20
• Device Lot Number: 2386488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention