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

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  Injury  

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 Description

Premature loosening of hip prosthesis.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

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 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
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8825885
• MDR Text Key: 152171629
• Report Number: 3002806535-2019-00626
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304202337
• UDI-Public: 00880304202337
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other