MAUDE Adverse Event Report: ZIMMER GMBH HUMERAL ANCHOR UNCEMENTED S

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: humeral head 40-14, catalog#: 0104555400 ; lot#: 2721916, therapy date: (b)(6) 2019.The manufacturer did not receive x-rays, or other source documents 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to pain.

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: it was reported that the devices were implanted on (b)(6) 2016 and revised on (b)(6) 2019 due to pain.The surgeon of the revision surgery mentioned to the zimmer biomet sales representative that the reason for revision is not a malfunctioning of the devices.Nevertheless, the reason for revision surgery is unknown.Review of received data: no medical data or patient information has been received due to hospital privacy policy.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - visual examination: the head shows some fine scratches on the articulation surface.On the anchor some bone attachments can be found, as well as some scratches on the taper surface.Otherwise, no considerable deteriorations, deformations or imperfections can be seen.- measurements: to ensure the humeral head has correct dimensions, characteristics according to inspection plan and product drawing were measured with caliper.Characteristic no.08 feature height 14 +0.2/-0.2.-specification: max.14.20 mm; min.13.80 mm.-measured value: 14.00 mm.The measured height is within the defined specification.Characteristic no.15 feature diameter 40 +0.3/-0.3.-specification: max.40.30 mm; min.39.70 mm.-measured value: 39.98 mm.The measured diameter is within the defined specification.The taper of the humeral head has been inspected in all 17 parts of lot 2721916 during manufacturing and all 17 tapers were found to be according to specification.The taper as well as the outer diameter of the ring of the humeral anchor has been inspected in all 17 released parts of lot 2813424 during manufacturing and all 17 tapers and diameters were found to be according to specification.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination (humeral head and humeral anchor) was approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the devices were implanted on(b)(6) 2016 and revised on (b)(6) 2019 due to pain.The reason for revision surgery is unknown.The humeral anchor and the humeral head were returned for investigation, which did not identify any product issue.Neither a detailed event description nor x-rays, operative notes, office visit notes or other medical records were received; therefore, the reason for revision remains unknown.Further, patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), relevant medical history and adherence to rehabilitation protocol are unknown.Based on the returned products the reported revision can be confirmed, nevertheless, the reason remains unknown.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 device examination, we were not able to identify a specific root cause for the revision surgery.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: HUMERAL ANCHOR UNCEMENTED S
• Type of Device: HUMERAL ANCHOR UNCEMENTED S
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9353089
• MDR Text Key: 167342261
• Report Number: 0009613350-2019-00688
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024397163
• UDI-Public: 00889024397163
• 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: 09/09/2020

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: 01.04555.110
• Device Lot Number: 2813424
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/09/2020
• 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