MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER GLENOID HEAD EXTREMITIES IMPLANT

Model Number N/A

Device Problem Material Disintegration (1177)

Patient Problem Muscle Weakness (1967)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted an unknown anatomical shoulder glenoid head extremities implant on an unknown date.The patient is scheduled for revision surgery on an unknown date due to wear of the glenoid component and rotator cuff deficiency.Additional information has been requested and is currently not available.

Manufacturer Narrative

As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive more information for this case.As no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it was reported that a patient was implanted with an anatomical shoulder on an unknown date and is scheduled for revision surgery on an unknown date due to wear of the glenoid component and rotator cuff deficiency.Review of received data - one x-ray picture (undated) is available.An implanted stem and humeral head can be seen.A small crack on the bone can be detected.No product was returned to zimmer biomet for in-depth analysis.Root cause analysis: root cause determination using dfmea: -poor reconstruction due to surgeon applied insufficient impaction forces to insert humeral stem => possible: no information provided about the initial surgery.- poor reconstruction, inability to attach humeral head due to surgeon misaligns humeral stem with respect to intended alignment => possible: no information provided about the initial surgery.-loss of function, reduced rom, glenoid damage, soft tissue damage due to compromised range of motion by incorrect design => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.- poor reconstruction, loss of function due to anatomical needs not met through design (geometry, offset) => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.- poor reconstruction due to size of implant components does not allow for ergonomic use (i.E.Sub-components of locking mechanism too small to handle) => possible: no information about the patient and surgery was provided.No surgical report of implantation was provided.- loss of function, reduced rom, glenoid damage, soft tissue damage due to compromised range of motion by incorrect design => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.- poor post-operative outcome.Due to implants used for defined contra-indication => possible: no information about patient condition or pre op information was provided.- poor surgical outcome, pain, insufficient function et al.Due to surgeon does not prepare bone (i.E.Osteophyte removal) or softtissues (i.E muscle repair) sufficiently prior to or post implantation => possible: no surgical report of implantation provided.Conclusion summary: neither detailed x-rays, operative notes, office visit notes, nor devices or photos of the implants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER GLENOID HEAD EXTREMITIES IMPLANT
• Type of Device: ANATOMICAL SHOULDER
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6344933
• MDR Text Key: 67803773
• Report Number: 0009613350-2017-00281
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other