MAUDE Adverse Event Report: ZIMMER GMBH ALLOCL CSF ANCHORAGE CAP 61; N/A

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 12/04/2013

Event Type  Injury  

Manufacturer Narrative

New information has been made available: ref: 01.00121.090, lot: 2318345, (alloclassic offset stem 9).Ref: 3535, lot: 2386833, (alloclassic csf anchor cup 61).Ref: 3525, lot: unknown, (alloclassic csf insert 61/32).Implantation report (46.Pdf).Revision report (47.Pdf & 48.Pdf).X-rays (images 31-44).Patient weight.Concomitant medical products: item#: 3525, name: alloclassic csf insert 61/32, lot#: unknown.Item#: 01.00121.090, name: alloclassic, sl stem, offset, uncemented, 9, lot#: 2318345.New information will be reviewed and the investigation will be updated, a additional report will be submitted when investigation results becomes available.(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.The following reports are associated with this event: 0009613350-2019-00397-3, 0009613350-2019-00623.

Event Description

It was reported that the patient underwent revision due to infection and fluid collection.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: infection.Event description: it was reported that the patient was implanted on (b)(6) 2007 with a total hip prothesis.Head and liner were revised on (b)(6) 2007 due to infection (see (b)(4).A new alloclassic insert and a competitor's (depuy) metal head were implanted.On (b)(6) 2013 all products were revised due to infection.Review of received data: multiple x-rays have been received.However, review of x-rays will not enhance investigation as infection is not visible in x-ray images.Initial implantation report dated: on (b)(6) 2007.Diagnosis: high degree of coxarthrosis right hip side.Procedure: cementless total hip procedure.No complications are noted.First revision report dated on (b)(6) 2007 (see (b)(4).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).No complications are noted.Second revision report dated on (b)(6) 2013.Diagnosis: infection.On the day before, 200ml pus with gram-positive coocus were extracted from the patient.Procedure: girdlestone symptom, removal of cup and stem during procedure, large amount of pus released.Large area of infection detected.Low grade infect.Removal of head and inlay.After removal of cup, pus is detected at the anchorage side.Upper third of stem is surrounded by infection tissue.Removal of stem requires a lot of effort.Bleeding in the area of the stem.Implantation of cerclage and cement spacer.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Compatibility: as the femoral head was manufactured from a competitor, the implants were found to be not compatible.An off-label use has been performed.Instruction for use for alloclassic stem and for alloclassic cup state that early or late infections are possible side effects and should be considered when implanting zimmer biomet devices.Moreover, they list general instructions, risk factors, sterilization instructions, storage and handling instructions.Conclusion: it was reported that the patient was implanted on (b)(6) 2007 with a total hip prothesis.Head and liner were revised on (b)(6) 2007 due to infection (see (b)(4).A new alloclassic insert and a competitor's (depuy) metal head were implanted.On (b)(6) 2013 all products were revised 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 for the known lot numbers.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 certificates of the affected known lots have been reviewed and was found to be according to specification.Moreover, no trend on infection has been observed for these part or known lot numbers.Therefore, it is highly unlikely that a disadvantageous product design or processing favored or contributed to the infection.As the infection has occurred after more than 6 years in vivo, a contribution of the implants is highly unlikely.However, the ifu for femoral stems and acetabular cups state that early or late infections are possible side effects 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.Moreover, an off-label use has been performed.It remains unknown whether this off label use has contributed to the reported event.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported infection.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).

• Brand Name: ALLOCL CSF ANCHORAGE CAP 61
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9201984
• MDR Text Key: 165590742
• Report Number: 0009613350-2019-00624
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 3535
• Device Lot Number: 2386833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2019
• 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
• Patient Weight: 98