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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: bihapro shell ha/pc 52mm ln 23, catalog #: 165743, lot #: 1170828, medical product: bihapro mk iii ha/pc sz6 lh t1, catalog #: 12-164566, lot #: 124027, medical product: bihapro fem pmma cntrlzr 13mm, catalog #: 164204, lot #: 1343577, medical product: delta ceramic fem hd 028/ 0mm, catalog #: 164136, lot #: 1673301.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00564, 3002806535-2019- 00618, 3002806535-2019-00617, 3002806535-2019-00620.Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.A review of the manufacturing history records confirms no abnormalities or deviations that could be related to the reported event.Root cause was unable to be determined.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.Product not returned.
Event or Problem Description
It has been reported by the patient's legal representative that the patient underwent an initial hip replacement surgery.Subsequently, a revision procedure was performed on due to avascular hip necrosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported by the patient's legal representative that the patient underwent an initial hip replacement surgery.Subsequently, a revision procedure was performed on due to avascular hip necrosis.

• 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: 8821557
• Report Number: 3002806535-2019-00619
• Device Sequence Number: 3027432
• Product Code: LPH
• UDI-Device Identifier: 00880304202337
• UDI-Public: 00880304202337
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K926107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-105903
• Device Lot Number: 2009020675
• 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: 08/08/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/10/2019
• 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: Required Intervention