MAUDE Adverse Event Report: ZIMMER GMBH FITMORE, HIP STEM, UNCEMENTED, B/5, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date: detail of product: item # 0101012367, item name cocr head, l, 36/+4, taper 12/14.Lot # unknown.Item # 00000004248, item name allofit alloclassic shl 58/ll, lot # unknown.Item # 0100013712, item name durasul, alpha insert, ll/36 lot # unknown, the manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Attempts to obtain additional information have been made; however, no more is available.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).Lot number unknown.
Event or Problem Description
Clinical study reported that patient experiencing pain which was communicated during post operative check ups.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Review of product documentation all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.No trend considering the following event is identified: pain.Event summary: it was reported that the patient was implanted with a total hip prosthesis on the left hip on (b)(6), 2008.Pain was noted 10 years post-surgery ((b)(6) 2018).Area of pain around the groin, trochanter and buttock.Review of received data - clinical study documents have been received: 3 month follow up: decreased hip pain, no pain medication.1 year follow up: no hip pain, no pain medication.2 years follow up ((b)(6) 2010): mild pain in lateral thigh occurring occasionally.Pain medications.3 years follow up ((b)(6) 2011): mild pain in anterior and lateral thigh occurring occasionally.Pain medications.10 years follow up ((b)(6) 2018): moderate pain in groin, trochanter and buttock.Pain medications.- implantation report dated (b)(6), 2008: diagnosis: coxarthritis left.Several months of pain when loading the joint.Surgery: cementless total hip prosthesis procedure: no complications noted.Post-operative correct implant positioning was noted.Patient is bilateral: hip prosthesis on right hip side was implanted in 2001.- doctor's letter dated (b)(6) 2019 from the spine surgical clinic.This document is found to be not relevant for the complaint, as it addresses the lumbar fracture.Devices analysis no product was returned to zimmer biomet for in-depth analysis as they remain implanted.Conclusion summary it was reported that the patient was implanted with a total hip prosthesis on the left hip on (b)(6), 2008.Mild pain was noted in the two and three years follow up in the anterior and lateral thigh.Moderate pain was noted in the groin, trochanter and buttock in the ten years follow-up.Patient takes pain medication.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.No x-rays have been received, therefore the correct implant positioning could not be assessed.Pain can have numerous root causes and cannot be related to a single failure mode.Based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2019-00431, 0009613350-2019-00432, 0009613350-2019-00433, 0009613350-2019-00434.

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, B/5, TAPER 12/14
• Common Device Name: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8758047
• Report Number: 0009613350-2019-00431
• Device Sequence Number: 1488816
• Product Code: KWA
• UDI-Device Identifier: 00889024483118
• UDI-Public: 00889024483118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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
• Patient Weight: 74