MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER HUMERAL STEM UNCEMENTED 10.5-100; ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received per 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 or Problem Description
During surgery the implant did not fit properly as it was too large even though the trial stem fit perfectly.Due to this the surgery was delayed by 35 minutes in order to get another stem with cement.
Additional Manufacturer Narrative
Additional information which was received on may 01, 2020.D11- medical product: anatomical shoulder reverse, humeral insert, pe, 36-0; item# 0104223360; lot# 3011036.Cannulated drill with stop 6 mm; item# 47430706100; lot# 64391471.Anatomical shoulder reverse, screw system, 4.5-30; item# 0104223030; lot# 2992083.Base plate 15 mm post length uncemented; item# 00434901500; lot# 64448806.Anatomical shoulder reverse, screw system, 4.5-33; item# 0104223033; lot# 2992086.Anatomical shoulder reverse, humeral cup, retro, +6 mm medial offset; item# 0104223106; lot# 3009752.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received x-rays and surgical reports which will be reviewed as part of ongoing investigation 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 or Problem Description
During surgery the implant did not fit properly as it was too large even though the trial stem fit perfectly.Due to this the surgery was delayed by 35 minutes in order to get another stem with cement.
Event or Problem Description
Investigation completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that during surgery on (b)(6) 2020 the trial stem had a perfect fit, but the final as implant was too large and had to be replaced leading to a surgical delay of around 35 minutes.Review of received data: x-rays: an x-ray review has been performed.All x-rays show the finally implanted reverse system.Therefore, the x-rays do not show the reported event.Surgical report: the surgical report of the implantation has been reviewed, however the reported event is not mentioned.Product evaluation: visual examination: in total seven nicks and indents can be seen on the blasted area and a few scratches and nicks on the flanks.Otherwise, the part is visually inconspicuous.Measurements: the length is within the defined specification.Characteristic "dimension 11.41 +0.1/-0.1".Specification: max.11.51 mm; min.11.31 mm.Measured value: 11.47 mm.The dimension is within the defined specification.Characteristic "dimension 13.63 +0.1/-0.1".Specification: max.13.73 mm; min.13.53 mm.Measured value: 13.64 mm.The dimension is within the defined specification.Characteristic "diameter 13.93 +0.1/-0.1".Specification: max.14.03 mm; min.13.83 mm.Measured value: 13.83 mm.The diameter is within the defined specification.Characteristic "diameter 12.02 +0.2/-0.2".Specification: max.12.22 mm; min.11.82 mm.Measured value: 11.96 mm.The diameter is within the defined specification.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 identified that 4 parts of lot 2978912 were scrapped, otherwise no deviations or anomalies during manufacturing were identified.Ncr(s): 3 parts of lot 2978912 were scrapped due to surface defects (ncr# (b)(4)) and 1 part of lot 2978912 was scrapped due to angle dimension out of specification (ncr# (b)(4)).All 17 parts of lot 2978912 were inspected, therefore there is no potential correlation to the reported event.Conclusion: it was reported that during surgery on (b)(6) 2020 the trial stem had a perfect fit, but the final as implant was too large and had to be replaced leading to a surgical delay of around 35 minutes.The product investigation showed that the product has correct dimensions.Therefore, based on the measurements the reported event cannot be confirmed.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 investigation no product issue could be identified.Therefore, it can only be assumed that the final rasp was not completely inserted into the humerus, leading to an inappropriate preparation of the implant bed.Further, as the trial stem has neither been reported nor returned, the trial stem could not be examined and any possible contributing factors to the reported event deriving from the trial stem could not be identified.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.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: ANATOMICAL SHOULDER HUMERAL STEM UNCEMENTED 10.5-100
• Common Device Name: ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9737936
• Report Number: 0009613350-2020-00077
• Device Sequence Number: 1815241
• Product Code: KWS
• UDI-Device Identifier: 00889024484917
• UDI-Public: 00889024484917
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04201.103
• Device Lot Number: 2978912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 07/08/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/28/2020; 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 62