MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN LINER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Event description: it was reported that the patient was initially implanted on (b)(6) 2010 and revised on (b)(6)2017 due to pain, slightly elevated metal ion levels,suspicion of loosening and fluid collection.On (b)(6) 2019 the patient underwent a second revision of head and liner due to pain and significant tissue reaction, and corrosion.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.Medical records were provided and reviewed by a health care professional.The patient underwent an initial r tha on (b)(6) 2010 due to osteoarthritis; no intraoperative complications were noted.The patient was revised (b)(6) 2017 due to pain and elevated metal ions.Pre/post diagnosis states possible metallosis but no mention of tissue condition, trunnionosis or other events related to metallosis.The patient was revised a second time on (b)(6) 2019 due to pain, significant tissue reaction and corrosion.Findings revision report: mild protrusion position of socket.Significant tissue reaction throughout hip & scarring, pseudocapsule debrided from response.Ceramic head removed and noted well-fixed stem, trunnionosis present & cleaned.Poly liner from shell, 3 screw caps of socket removed, 1 screw had been stripped.Pocket well fixed.Lateralized poly liner was impacted, morse taper cleaned and dried, +7.5 mm head impacted.Moreover, the revision surgical report dated 25 jun 2019 states: mri does show soft tissue changed.Metal ions are no longer elevated.Difficult to determine what is causing the pain.No guarantee that exchange of head and liner will change the problem.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination could not be analyzed due to unknown product identification.Conclusion: it was reported that the patient was initially implanted on (b)(6) 2010 and revised on (b)(6)2017 due to pain, slightly elevated metal ion levels,suspicion of loosening and fluid collection.On (b)(6) 2019 the patient underwent a second revision of head and liner due to pain and significant tissue reaction, and corrosion.Based on the investigation the reported event cannot be confirmed.Pain cannot be related to one specific failure mode.Moreover, as neither the retrievals nor photos of the retrievals were received; the condition of the components is unknown.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 gmbh considers this case as closed.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 continued pain and mildly protruded socket.Mri showed soft tissue changes.

• Brand Name: UNKNOWN LINER
• Type of Device: UNKNOWN LINER
• 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: 10874447
• MDR Text Key: 217323370
• Report Number: 0009613350-2020-00543
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN LINER HIP
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/20/2020
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP
• Patient Outcome(s): Hospitalization; Required Intervention