MAUDE Adverse Event Report: ZIMMER GMBH SULOX, HEAD, L, 32/+3.5, TAPER 12/14; N/A

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 10/31/2007

Event Type  Injury  

Manufacturer Narrative

X-rays, surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.Concomitant medical products: item: alloclassic csf insert 61/32, item#: 3525, lot#: 2339405.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).Note: patient underwent two revision surgeries: (b)(4) captured revision of the hip tep due to infection.(b)(4) captured the first revision due to infection sulox head and insert.

Event Description

It was reported that the patient underwent a revision surgery due to infection.

Manufacturer Narrative

Investigation results were made available.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: part specific investigation: no trend considering the following event is identified: infection lot specific investigation: no lot trend: no additional similar investigated events for the lot numbers 2339405 and 2398130 have been found.Review of event description: it was reported that the patient was implanted with a total hip prosthesis on (b)(6)` 2007 and the head and liner were revised on oct 31, 2007 due to infection.Review of received data x-rays: one post-implantation x-ray dated (b)(6) 2007 and one post-revision x-ray dated (b)(6) 2007 has been received.No x-ray analysis was performed, as it would not contribute to the investigation due to the x-rays dates.Implantation report dated (b)(6) 2007: diagnosis: high degree of coxarthrosis right hip side.Procedure: cementless total hip procedure.No complications are noted.Explantation report dated (b)(6) 2007: diagnosis: early infection (secretion due to soft tissue and joint infection) procedure: synovectomy combined with debridement.Change of head and inlay.Removal of inlay.No signs of infection in the area of the cup.Cup is well seated.Cone of the stem is cleaned.Reimplantation of a new alloclassic inlay and depuy femoral head (competitor¿s product).No complications are noted.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation all involved devices are intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Instruction for use (ifu) for sulox head and for alloclassis insert state that early or late infections are possible consequences of an implant and should be considered when implanting zimmer biomet devices.Moreover, general instructions, risk factors, sterilization instructions, storage and handling instructions are listed.Conclusion summary it was reported that the patient was implanted with a total hip prosthesis on (b)(6) 2007 and the head and liner were revised on oct 31, 2007 due to infection.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.The gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot has been reviewed and was found to be according to specification.Moreover, no trend on infection has been observed for these part or lot numbers.Therefore, it is highly unlikely that a disadvantageous product design or processing favored or contributed to the infection.However, the ifu for endoprosthesis states that early or late infections are possible consequences of an implant and should be considered when implanting zimmer biomet devices.Nevertheless, an infection can have numerous root causes.Possible causes of infection include wrong handling of device due to wrong information, wrong re-sterilization procedures for sterile delivered parts or packaging failure during transportation.However, based on the available information, an exact root cause for the infection could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.

• Brand Name: SULOX, HEAD, L, 32/+3.5, TAPER 12/14
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9139097
• MDR Text Key: 166735813
• Report Number: 0009613350-2019-00581
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/30/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 17.32.07
• Device Lot Number: 2398130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/30/2019
• 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