MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, B/6, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Medical product.Sulox head, m, 㸠32/0, taper 12/14; catalog no#: 173206; lot#: unknown.Fitmoreâ® hip stem, trial rasp, b/6; catalog no#: 0100559206; lot#: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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

During implantation of fitmore stem, the planned gr b6 was achieved with the form rasp, a trial reduction with radiological size control was performed.The desired surgical result was achieved.After the removal of the rasp, the original size b6 was implanted and the situation arose that the shaft looked 10 mm further out of the shaft than the rasp.The original was explanted and the rasp 5 & 6 prepared again.The subsequent result was the same.Surgeon decided to implant the original b5, which was then firmly seated in the femur.Surgery was delayed/extended for 35 minutes.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g4, g7, h10 event description: it was reported that during implantation of fitmore stem on (b)(6), 2020 the planned gr b6 was achieved with the form rasp, a trial reduction with radiological size control was performed.The desired surgical result was achieved.After the removal of the rasp, the original size b6 was implanted and the situation arose that the shaft looked 10 mm further out of the shaft than the rasp.The original was explanted and the rasp 5 & 6 prepared again.The subsequent result was the same.Surgeon decided to implant the original b5, which was then firmly seated in the femur.It is also reported, that the surgery was delayed/extended for 35 minutes and that the instruments were used approximately 300 times.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the rasps show some normal signs of consistent usage.The stem shows scratches around the neck region and some polished spots in the distal part of the stem distal to the ha coating.The head shows some metallic smearing which most likely occurred during handling.Nothing conspicuous was revealed during the visual examination.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr / ncr review: review of the device history records identified two ncrs: 2 pieces were scraped as they were initial samples to adjust the machine (ncr# 500085907) and afterwards all remaining 68 were measured and accepted for further manufacturing (ncr# 500085908); 1 piece was scraped as it showed a damaged thread (ncr# 500086437) - the ncr and dhr review showed that all released products met the specifications valid at the time of production.Inspection plan: the inspection plan was reviewed and revealed that several characteristics along the stem such as the dimensions of the cross section were measured 100% with a 3d measuring machine.Conclusion: it was reported that during implantation of fitmore stem on (b)(6), 2020 the planned gr b6 was achieved with the form rasp, a trial reduction with radiological size control was performed.The desired surgical result was achieved.After the removal of the rasp, the original size b6 was implanted and the situation arose that the shaft looked 10 mm further out of the shaft than the rasp.The original was explanted and the rasp 5 & 6 prepared again.The subsequent result was the same.Surgeon decided to implant the original b5, which was then firmly seated in the femur.It is also reported, that the surgery was delayed/extended for 35 minutes and that the instruments were used approximately 300 times.Nothing conspicuous was revealed during the visual examination.As reported the rasps have been used for several times without reporting any deviations.Further, the manufacturing documents confirm that the rasps were manufactured according to specifications.Additionally, a complaint history search for the rasps was done in order to determine if any other similar reported issues have been received.No additional complaints for the same references were found.Therefore, it is assumed that the rasps did not contribute to the reported event.The review of the manufacturing records also showed that the stem was measured during production and that all released products met the specifications valid at the time of production.Additionally, a complaint history search for the reference (b)(4) and lot 2995556 was done in order to determine if any other similar reported issues have been received.No additional complaints for the same reference and lot combination were found.The affected stem was manufactured in 2019.All components related to this lot are already on the market without any complications reported.Based on the investigation the reported event cannot be confirmed and no further containment actions are required.The investigation did not identify a nonconformance or a complaint out of box (coob).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.

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, B/6, TAPER 12/14
• Type of Device: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10137666
• MDR Text Key: 194642732
• Report Number: 0009613350-2020-00251
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024483125
• UDI-Public: 00889024483125
• Combination Product (y/n): N
• PMA/PMN Number: K071723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.206
• Device Lot Number: 2995556
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization