MAUDE Adverse Event Report: ZIMMER GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/9, TAPER 12/14; FITMORE HIP STEM B EXT. OFFS., SIZE 9

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays 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.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).

Event Description

Patient was implanted on the right side and underwent revision surgery due to elevated metal ions / wear / trunnionosis / pseudo-tumor.

Manufacturer Narrative

Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.No trigger considering the following event is identified: elevated cobalt levels,pseudotumor, pain, wear and corrosion.Event summary: it was reported that the product was implanted on (b)(6) 2014 and revised on (b)(6) 2019 due to elevated cobalt levels, pseudotumor, pain, wear and corrosion.Review of received data review of legal document: on (b)(6) 2018 patient reported pain.On (b)(6) 2018 the patient had an x-ray of the hip and he was found to have a pseudo tumor present.Lab results showed cobalt levels elevated at 4.2mcg/l.During the revision surgery on (b)(6) 2019 the surgeon found signs of fretting and corrosion, which included black corrosion debris, the presence of pseudo-tumors and metal debris at the hip/neck junction.Blackening of the trunnion (trunnionosis).Metal staining of the inferior hip synovium.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion summary: it was reported that the product was implanted on (b)(6) 2014.On (b)(6) 2018 pain was reported by patient.On (b)(6) 2018 the patient had an xray of the hip and he was found to have a pseudo tumor present.Lab results showed cobalt levels elevated at 4.2mcg/l.During the revision surgery on (b)(6) 2019 the surgeon found corression and metal debris at the hip/neck junction.In vivo time of the device was 4 years 6 months.Based on the given information the complaint could not be confirmed.Dhr review of products could not be performed since no lot was reported.The investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Therefore, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being filled to relay investigation update.Detail of product: item number 00801803604, item name femoral head sterile product do not resterilize 12/14 taper, lot # 62340149.Item number 00625006535, item name bone screw self-tapping 6.5 mm dia.35 mm length, lot # 62622418.Item number 00875706401, item name shell with cluster holes porous 64 mm o.D.Size oo for use with oo liners, lot # 62522347.Item number 0087521636, item name hxpe liner elevated oo 36, lot # 61495536.Trend analysis: no trend has been identified.Event description: it was reported that the product was implanted on (b)(6) 2014 and revised on (b)(6) 2019 due to elevated cobalt levels,pseudotumor, pain, wear and corrosion.Review of received data: indication for implant surgery was severe right hip osteoarthrosis review of legal letter: on (b)(6) 2018 the patient had an x-ray of the hip and he was found to have a pseudo tumor present.Lab work showed cobalt levels elevated at 4.2mcg/l.During the revision surgery on (b)(6) 2019 the surgeon found signs of fretting and corrosion, which included black corrosion debris, the presence of pseudo-tumors and metal debris at the hip/neck junction.Blackening of the trunnion (trunnionosis).Metal staining of the inferior hip synovium.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 27-apr-2020.The review showed that the materials were manufactured according to specification.Conclusion: it was reported that the product was implanted on (b)(6) 2014.On (b)(6) 2018 pain was reported by patient.On (b)(6) 2018 the patient had an xray of the hip and he was found to have a pseudotumor present.Lab results showed cobalt levels elevated at 4.2mcg/l.During the revision surgery on (b)(6) 2019 the surgeon found corrosion, fretting and metal debris at the hip/neck junction.In vivo time of the device was 4 years 6 months.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.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).

Event Description

Please refer to report 0009613350 - 2019 - 00477.

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/9, TAPER 12/14
• Type of Device: FITMORE HIP STEM B EXT. OFFS., SIZE 9
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8877774
• MDR Text Key: 153787640
• Report Number: 0009613350-2019-00477
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K071723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.309
• Device Lot Number: 2705643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR