MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN ANATOMICAL SHOULDER HUMERAL INSERT; N/A

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

The product in this report is manufactured by zimmer biomet (b)(4), exact identification numbers have not been provided however this report is being submitted because similar devices are cleared or distributed in the united states.Concomitant medical products: anatomical shoulder humeral cup, item# unknown, lot# unknown.Anatomical shoulder stem, item# unknown, lot# unknown.Anatomical shoulder glenoid fixation, item# unknown, lot# unknown.Device history record (dhr) review could not be performed as the lot number of the device involved in the event is unknown.The manufacturer did not receive x-rays, or other source documents for review.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.The following report is associated with this event 0009613350-2019-00231.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

It was reported that the patient underwent a revision surgery due to pain and possible scapular notching.There was also signs of wear on the inlay.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Investigation results were made available.Dhr review: as no lot number was provided, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh 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 gmbh 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.Trend analysis: analysis could not be performed as no item numbers are available.Event description: due to a revision surgery because of pain and scapular notching, an exchange of a cup and an inlay was planned, so that the surgeon could reach certain areas for the correction.There was no malfunction regarding the implant.Because the original as-shaft was left, the impaction of the cup was done in situ.After that a trial reduction with the mentioned trial inlay was done.Due to the removal of the trial inlay the fixing springs broke (treated in (b)(4)).Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis as the explants remain with the patient.Review of product documentation: all involved devices are intended for treatment.Conclusion summary: due to a revision surgery because of pain and scapular notching, an exchange of a cup and an inlay was planned, so that the surgeon could reach certain areas for the correction.There was no malfunction regarding the implant.Because the original as-shaft was left, the impaction of the cup was done in situ.After that a trial reduction with the mentioned trial inlay was done.Due to the removal of the trial inlay the fixing springs broke (treated in (b)(4)).The revision surgery was due to pain and possible scapular notching, which is why (b)(4) was created.There were also signs of wear on the inlay.The revision was done on (b)(6) 2019.The implantation time is unknown.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted 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.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the given information and performed investigation, the complaint could not be confirmed.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).The following reports are associated with this event: 0009613350 - 2019 - 00231 - 1.

Event Description

Investigation results have been made available.

• Brand Name: UNKNOWN ANATOMICAL SHOULDER HUMERAL INSERT
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8526893
• MDR Text Key: 142339237
• Report Number: 0009613350-2019-00232
• Device Sequence Number: 1
• Product Code: HSD
• 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: 07/15/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/15/2019
• 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