MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Medical products: b-s reinforcement cage hip impl win gen; catalog#: unknown; lot#: unknown.Muller cup hip impl win gen; catalog#: unknown; lot#: unknown.Biolox head hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer received x-rays and 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.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

It was reported that the patient was implanted on the left side and has suffered from recurrent infections which was treated by wound revision.The samples taken at necrosectomy on (b)(6) 2019 were positive for corynebacteria.Hip revision was performed along with debridement and sealing with an absorbable antibiotic carrier was made.The patient had to be hospitalized as an emergency case on (b)(6) 2019 due to a recurrence of an infection on the left hip.Hip revision was performed where the implanted components were preserved and necrosectomy, debridement, insertion of a non-absorbable antibiotic carrier and drainage was made.On (b)(6) 2019 a wound revision was performed due to a very difficult soft tissue and periprosthetic infection situation.

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported that the patient received an implant on (b)(6) 2019.The patient was suffering from recurrent infection and underwent several wound revisions with no device revisions.Harm: s3 - infection, moderate localized hazardous situation: patient¿s anatomy is exposed to agents/substances of unknown origin.2.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: x-rays were provided; however, they were not reviewed as an infection is not visible on an x-ray.Surgical reports: review of the operative report dated (b)(6) 2019 identified a surgical procedure for a skin necrosis at the intersection of 2 scars and a subcutaneous/subfascial hematoma.The wound was cleaned and evacuated, with the patient receiving antibiotics post-operation.Review of the operative report dated (b)(6) 2019 identified tissue samples taken (b)(6) 2019 tested positive for corynebacterium.The patient underwent surgical intervention for debridement and implantation of an absorbable antibiotic carrier.The patient received antibiotics post operation.Review of the operative report dated (b)(6) 2019 identified that the patient was hospitalized on (b)(6) 2019 for infection (e.Cloacae) with abscesses and skin necrosis.The patient then underwent a surgical intervention for necrosectomy, debridement and insertion of a non-absorbable antibiotic carrier.The patient received antibiotics post-operation.Review of the operative report dated (b)(6) 2019 identified two wound drains were placed and wound dehiscence occurred.The patient received antibiotics post-operation.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.5.Conclusion: it was reported that the patient received an implant on (b)(6) 2019.The patient was suffering from recurrent infection and underwent several wound revisions with no device revisions.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or 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 switzerland manufacturing 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: 0009613350-2021-00424-1, 0009613350-2021-00428-1, 0009613350-2021-00429-1.

Event Description

Investigation results are now available.

• Brand Name: WAGNER STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12364197
• MDR Text Key: 268022483
• Report Number: 0009613350-2021-00426
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 101 KG