MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 10.5, 100 MM; 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 Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: anatomical shoulder, rasp for humeral stem, 10.5; catalog no #: 0104233105/e; lot #: unknown.The manufacturer did receive per, implant image, notification of a complication with a medical device for review.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
Patient was implanted on the unknown side and during surgery the stem did not fit hence the surgery was completed using a another size stem.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d9, h2, h6 correction: b4, b5, g3, g6, h3, h10 review of event description: it was reported that during surgery on jun 17, 2020 after preparation the implant would not fit properly and it seemed larger.The humerus was prepared using a 10.5 rasp and stem of size 10.5 would not fit.Therefore, the surgery was completed using a size 9 cemented stem.The procedure was finished successfully and there were no consequences for the patient review of received data: - no medical data relevant to the case has been received.- 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 humeral stem shows some cuts on the anchoring surface especially on the lateral side.Further, the taper seems to be damaged.Both observations most likely derive from instruments during the surgery.The visual examination shows no considerable deteriorations on the rasp.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: 'the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during surgery on (b)(6) 2020 after preparation the implant would not fit properly and it seemed larger.The humerus was prepared using a 10.5 rasp and stem of size 10.5 would not fit.Therefore, the surgery was completed using a size 9 cemented stem.The procedure was finished successfully and there were no consequences for the patient the visual examination shows no considerable deteriorations for the rasp and the stem.The product investigation also showed that both devices have the correct dimensions.Based on the investigation 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.If the final rasp was not completely inserted into the humerus cannot be determined based on the available information and investigation.If and to what extent other factors might have contributed to the reported also remains unknown.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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 10.5, 100 MM
• Common Device Name: ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10272298
• Report Number: 0009613350-2020-00321
• Device Sequence Number: 19033471
• Product Code: KWS
• UDI-Device Identifier: 00889024484917
• UDI-Public: 00889024484917
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K142403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04201.103
• Device Lot Number: 2883000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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