MAUDE Adverse Event Report: BIOMET UK LTD. ARCOM 32MM RNGLOC LNR HWALL 23; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: mlry-hd 3hole rlc shl 50mm/l23 ; catalog #: 11-104150 ; lot #: 3878335.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by the hospital that during a hip joint arthroplasty there was incorrect sized product in the packaging.In the package labeled as size ''23'', the actual product was size ''24''.An additional product was opened with the same lot number and the same issue was noted.To complete the procedure competitors product was used.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current manufacturer.This event will be reported by medwatch facility warsaw biomet (b)(4).
Event or Problem Description
Incorrect product in packaging.

• Brand Name: ARCOM 32MM RNGLOC LNR HWALL 23
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9161721
• Report Number: 3002806535-2019-00798
• Device Sequence Number: 2022883
• Product Code: JDI
• UDI-Device Identifier: 00880304202559
• UDI-Public: 00880304202559
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-105923
• Device Lot Number: 6450836
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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