MAUDE Adverse Event Report: BIOMET UK LTD. ARCOM 28MM RNGLOC LNR HWALL 23; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cocr hd xl nk 32 +8mm 12/14, part# p0206e32 and lot# 00j3235769, bihapro shell ha/pc d62 w/plgs th plugs with part# 165748t and lot# 3380341, taperloc bmpc 12.5x145mm 12/14 with part# 650-0555bm and lot# 3249776.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00625, 3002806535-2019- 00627,3006946279-2019-00335.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Premature loosening of hip prosthesis.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Premature loosening of hip prosthesis.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

• Brand Name: ARCOM 28MM 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: 8825885
• Report Number: 3002806535-2019-00626
• Device Sequence Number: 11426578
• Product Code: LPH
• UDI-Device Identifier: 00880304202337
• UDI-Public: 00880304202337
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-105903
• Device Lot Number: 3220734
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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
• Outcome Attributed to Adverse Event: Other